Methods of using applicator instruments for securing prosthetic devices to tissue

ABSTRACT

A method of securing a prosthetic device to tissue includes providing an applicator instrument including a housing, a shaft, surgical fasteners, a firing rod for dispensing the surgical fasteners from the shaft, a trigger, and an energy storing element. The method includes positioning a prosthetic device over tissue, juxtaposing a distal end of the shaft with the prosthetic device, and compressing the trigger for piloting the firing rod toward the distal end of the elongated shaft at a first rate of speed. The method includes preventing the firing rod from moving distally while building up energy in the energy storing element, and further compressing the trigger for releasing the firing rod for distal movement and transferring the built up energy for moving the firing rod toward the distal end of the elongated shaft at a second rate of speed that is greater than the first rate of speed.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of commonly assigned U.S.patent application Ser. No. 12/464,143, filed May 12, 2009, which isrelated to the following commonly assigned U.S. patent applications:U.S. patent application Ser. No. 12/464,151, filed May 12, 2009, nowU.S. Pat. No. 8,579,920, U.S. patent application Ser. No. 12/464,165,filed May 12, 2009, now U.S. Pat. No. 8,728,098, and U.S. patentapplication Ser. No. 12/464,177, filed May 12, 2009, now U.S. Pat. No.8,728,099. The disclosures of the above-identified patent applicationsand patents are hereby incorporated by reference herein.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention generally relates to surgical fasteners, and morespecifically relates to applicator instruments, systems and methods fordeploying surgical fasteners.

2. Description of the Related Art

Hernia is a condition where a small loop of bowel or intestine protrudesthrough a weak place or defect within the abdominal muscle wall or groinof a patient. This condition commonly occurs in humans, particularlymales. Hernias of this type may result from a congenital defect wherebythe patient is born with this problem, or may be caused by straining orlifting heavy objects. Heavy lifting may be known to create a largeamount of stress upon the abdominal wall and can cause a rupture ortearing at a weak point of the abdominal muscle to create the defect oropening. In any case, the patient may be left with an unsightly bulge ofintestinal tissue protruding through the defect, which may result inpain, reduced lifting abilities, and in some cases, impaction of thebowel, or possibly other complications if the flow of blood is cut offto the protruding tissue.

A common solution to the above-described problem may be surgery. Duringa surgical procedure, the defect is accessed and carefully examined,either through an open incision or endoscopically through an access portsuch as a trocar. In either case, careful examination is required due tothe network of vessels and nerves which exist in the area of a typicaldefect, which requires a surgeon to conduct a hernia repair with greatskill and caution. Within this area can be found vascular structuressuch as gastric vessels, the external iliac vessels, and the inferiorepigastric vessels, as well as reproductive vessels such as the vasdeferens extending through the inguinal floor.

Once the surgeon is familiar with the anatomy of a patient, the surgeoncarefully places the viscera back into the patient's abdomen through thedefect. Repairing the defect can involve closure of the defect withsutures or fasteners but generally involves placing a surgicalprosthetic such as a mesh patch over the open defect, and attaching themesh patch to the abdominal wall or inguinal floor with conventionalsuture or with surgical fasteners. The mesh patch acts as a barrier andprevents expulsion of bowel through the defect. Suturing of the meshpatch to the inguinal floor can be well suited to open procedures butcan be much more difficult and time consuming with endoscopicprocedures. With the adoption of endoscopic surgery, endoscopic surgicalinstruments that apply surgical fasteners can be used. However, thetissue of the inguinal floor may offer special challenges to the surgeonwhen a needle or fastener is used to penetrate structures such asCooper's ligament.

At present, there are a variety of surgical instruments and fastenersavailable for the surgeon to use in an endoscopic or open procedure toattach the mesh patch to the inguinal floor. One of the earliest typesof endoscopic surgical instruments used is a surgical stapler. Aplurality or stack of these unformed staples may be generally containedwithin a stapling cartridge in a serial fashion, and may be sequentiallyadvanced or fed within the instrument by a spring mechanism. A secondaryvalving or feeding mechanism may be employed to separate the distal moststaple from the stack, to hold the remainder of the spring loaded stack,and may be used to feed the distal most staples into the staple formingmechanism. Feeding mechanisms of this type are found in U.S. Pat. No.5,470,010 to Rothfuss et al., and in U.S. Pat. No. 5,582,616, also toRothfuss et al.

Another hernia mesh attachment instrument uses a helical wire fastenerthat resembles a small section of spring. Multiple helical wirefasteners may be stored serially within the 5 mm shaft, and may becorkscrewed or rotated into tissue. A load spring may be used to bias orfeed the plurality of helical fasteners distally within the shaft. Aprotrusion extends into the shaft to possibly prevent the ejection ofthe stack of fasteners by the load spring and may permit passage of arotating fastener. Instruments and fasteners of these types are found inU.S. Pat. No. 5,582,616 to Bolduc et al., U.S. Pat. No. 5,810,882 toBolduc et al., and in U.S. Pat. No. 5,830,221 to Stein et al.

Whereas the above surgical instruments may be used for hernia fasteningapplications, they use a spring mechanism to feed a plurality offasteners through the surgical instrument. Spring mechanisms typicallyuse a long soft coil spring to push a stack of fasteners through a guideor track within the shaft of the surgical instrument. These types offeeding mechanisms may be generally simple and reliable, but may requirean additional secondary valving mechanism or protrusion to separate andfeed one fastener from the stack.

Other surgical fasteners may be used for hernia mesh attachment bututilize either a reloadable single shot instrument or a rotary magazinethat holds a small number of fasteners. These types of surgicalfastening instruments can be found in U.S. Pat. No. 5,203,864 and U.S.Pat. No. 5,290,297, both to Edward Phillips. These instruments have notgained acceptance by the surgical community, possibly due to theirsingle shot capabilities and the large size of the rotary magazine,which can restrict such an instrument to an open procedure.

Whereas all the above surgical instruments may be used for herniafastening applications, they either use a spring mechanism to feed theplurality of fasteners through the surgical instrument, or a rotarymagazine in lieu of a feeding mechanism. Other types of surgicalfasteners may be available, such as surgical clips, and they can utilizefeeding mechanisms that do not require the use of a spring to feed theclips distally. A reciprocating feeding mechanism is described in U.S.Pat. Nos. 5,601,573; 5,833,700; and U.S. Pat. No. 5,921,997 to Fogelberget al. The Fogelberg et al. references teach a clip applier with afeeding mechanism that utilizes a reciprocating feed bar to feed aserial stack of clips. A feeder shoe may operably engage with and movewith the distally moving feed bar and may slidingly engage with theproximally moving feed bar. Thus, the feeder shoe may index or push thestack of clips distally with the distally moving feed bar and remainsstationary relative to the proximally moving feed bar. A valvingmechanism may be also required to separate the distal-most clip from thestack and to hold the stack stationary as the distal most clip may beapplied onto a vessel. Whereas the Fogelberg et al. references teach areciprocating feeding mechanism with a single reciprocating member, theydo not teach the use of the clip applier in the attachment of herniamesh, nor do they teach the individual driving or feeding of each clipby a moving member.

Another fastener feeding mechanism that uses reciprocation is thatdisclosed in U.S. Pat. No. 4,325,376 to Klieman et al. A clip applierthat stores a plurality of clips in a serial fashion within a clipmagazine is disclosed. The clips are in a stack wherein the proximalmost clip may be pushed or fed distally by a pawl that may be ratchetedor indexed distally by a reciprocating member or ratchet blade with eachactuation of the instrument. As the pawl indexes distally, it can pushthe stack of clips distally. A secondary valving mechanism may be alsodescribed. Thus, the feeding mechanism of Klieman et al. teaches the usea single reciprocating member and pawl to push or feed the stack ofclips distally, and may require a secondary valving mechanism to feedthe distal most clip.

U.S. Pat. No. 3,740,994 to DeCarlo Jr. describes a novel reciprocatingfeeding mechanism that may index a plurality of staples or clips, andmay ready them for discharge by reciprocating one of a pair of opposingleaf spring assemblies. The staples reside serially within a guide railwith a fixed leaf spring assembly extending into the plane of the guiderail. A reciprocating leaf spring assembly may opposedly extend inwardlytowards the fixed leaf spring assembly. As the reciprocating leaf springassembly moves distally, each of individual leaf springs of the assemblymay engage a staple and move it distally. The distally moving staplesdeflect the local individual leaf springs of the fixed leaf springassembly, and the deflected leaf springs may return to the un-deflectedposition after passage of the staple. As the moving leaf spring assemblymoves proximally, the leaf springs of the fixed leaf spring assemblyhold the staples stationary and prevent proximal movement thereof. Asecondary guide rail and valving mechanism may be provided to separate asingle staple from the stack for forming and can hold the stack ofstaples stationary as the single clip is formed.

Additionally, similar feeding mechanisms are disclosed in U.S. Pat. No.4,478,220 to DiGiovanni et al. and U.S. Pat. No. 4,471,780 to Menges etal. Both of these related patents teach a reciprocating feedingmechanism that uses one fixed member and one reciprocating member tofeed or index a plurality of clips distally. Angled flexible fingers maybe hingedly attached to the reciprocating member and operatively engagethe clips when moving distally, and slidingly engage with the clips whenmoving proximally. The angled flexible fingers within the fixed memberdeflect out of the way when the clips move distally and spring up tostop proximal movement of the clip after the clip has passed. Asecondary valving mechanism is also disclosed.

Commonly assigned U.S. Patent Application Publication No. 2002/0068947,the disclosure of which is hereby incorporated by reference herein,teaches a device for delivering a plurality of individual surgicalfasteners. In one embodiment, the delivery device includes a drivemechanism having distal and proximal ends. The drive mechanism has amoving member and a fixed opposing member, whereby the moving member ismoveable proximally and distally with respect to the delivery device.The moving member has a sharpened distal end for piercing tissue. Thedevice includes at least one surgical fastener located between the firstand the second members. Each of the at least one surgical fasteners hasa proximal end and a distal end. The device also has an actuator havingat least two sequential positions. A first position for moving themoving member distally and piercing tissue, and a second position formoving the moving member proximally, thereby deploying the distal end ofthe fastener.

Tacks for fixing meshes used laparoscopically have generally been madeof metal, such as stainless steel, nitinol, or titanium. The metal tackswere necessary to provide for sufficient holding strength, penetrationof various prosthetic meshes, and for ease of manufacture. Untilrecently, there were no absorbable tacks available on the market, andsurgeons could only use absorbable sutures in order to provide afixation means that did not permanently stay in the body. However, usingsutures is exceedingly difficult for laparoscopic procedure, and so theyare generally not used unless the repair is done in an open fashion.With surgical trends leading to more minimally invasive techniques withminimum foreign body accumulation, an absorbable tack with minimumprofile that can be applied laparoscopically is needed.

In spite of the above advances, there remains a need for furtherimprovements. In particular, there remains a need for surgical fastenershaving a minimum profile, surgical fasteners that may be appliedlaparoscopically, and surgical fasteners that are absorbable.

SUMMARY OF THE INVENTION

In one embodiment, the present invention discloses an applicatorinstrument and methods for consistently deploying surgical fasteners. Inone embodiment, the applicator instrument is used to hold a prostheticdevice such as surgical mesh in place over tissue. In one embodiment,the applicator instrument includes a mechanism for positioning asurgical fastener in line with a firing rod. The applicator instrumentpreferably includes a firing system that initially advances the firingrod toward the surgical fastener at a first speed. In one embodiment,energy may be stored in the firing system as the firing rod is advancedor piloted toward the surgical fastener. The firing system desirablyengages the surgical fastener with the firing rod while maintaining thesurgical fastener in a stationary position. The firing system preferablyreleases the stored energy to advance the firing rod at a second speedthat is greater than the first speed to deploy the surgical fastenerinto tissue. In one embodiment, one surgical fastener is dispensedduring one cycle of the firing system. A plurality of surgical fastenersmay be dispensed for securing a prosthesis such as a surgical mesh totissue.

In one embodiment, an applicator instrument for dispensing surgicalfasteners preferably includes a housing, and an elongated shaftextending from the housing having a proximal end coupled with thehousing and a distal end remote therefrom. The applicator instrumentdesirably includes a firing system for dispensing surgical fastenersfrom the distal end of the elongated shaft. The firing system preferablyincludes a firing rod disposed in the elongated shaft, and desirably hasa firing cycle with a first stage for advancing the firing rod towardthe distal end of the elongated shaft at a first rate of speed and asecond stage for advancing the firing rod toward the distal end of theelongated shaft at a second rate of speed that is greater than the firstrate of speed.

In one embodiment, a distal end of the firing rod includes an insertionfork. The applicator instrument is adapted to slowly pilot the insertionfork into a lead surgical fastener followed by quick firing of thesurgical fastener through a prosthetic device and into tissue. Prior artdevices rapidly advance a pushing element in one motion through afastener in a hammer-like manner while continuing to drive the fastenerinto tissue, or slowly engage a fastener at the same rate for slowlydriving the fastener into tissue. The first type of prior art device islimited in its ability to engage the fastener in a secure manner toassure the fastener's proper insertion into tissue. The first“hammer-like” prior art device may also damage the surgical fastener dueto impact force or may require the use of a massive fastener adapted towithstand impact forces. The second type of prior art device does notadvance the fastener fast enough to avoid tissue tenting and to enableproper tissue penetration. Both of these prior art approaches do notlend themselves to consistent and repeatable fastener penetration intotissue. In one embodiment, the present invention solves theselimitations by slowly piloting an insertion fork into a lead surgicalfastener, which assures proper engagement of the insertion fork with thesurgical fastener. After proper engagement, the present invention alsoprovides for quick firing of the surgical fastener through a prostheticdevice and into tissue. As a result, each surgical fastener ispreferably inserted the same way regardless of the speed of a user'strigger squeeze.

In one embodiment, the distal end of the firing rod is coupled with atleast one of the surgical fasteners during the first stage of the firingcycle, and the distal end of the firing rod dispenses the at least oneof the surgical fasteners from the distal end of the elongated shaftduring the second stage of the firing cycle. The firing system mayinclude an energy storing element such as a firing spring coupled withthe firing rod, whereby the firing system is adapted to store energy inthe firing spring before the second stage of the firing cycle andtransfer the stored energy from the firing spring to the firing rodduring the second stage of the firing cycle. In certain embodiments, theenergy storing element may also include a pneumatic device, a hydraulicdevice and/or a compressed gas device.

In one embodiment, the applicator instrument includes an actuatormovable between a first position and a second position for activatingthe firing system. The actuator may be a squeezable trigger thatactivates the firing system. In one embodiment, the firing spring is atleast partially compressed prior to the first stage of the firing cycle,and the firing rod advances distally at a rate that is proportional tomovement of the actuator during the first stage of the firing cycle. Thefiring spring is preferably compressible for storing energy therein asthe actuator moves from the first position to the second position. Theenergy stored in the firing spring is released during the second stageof the firing cycle for rapidly driving the firing rod toward the distalend of the elongated shaft. Although many of the embodiments disclosedherein refer to a “firing spring”, it is contemplated that other energystoring devices, such as those disclosed above may be used and stillfall within the scope of the present invention.

In one embodiment, the firing system preferably includes a release latchthat constrains the firing rod from moving toward the distal end of theelongated shaft after the first stage of the firing cycle and before thesecond stage of the firing cycle. At a preferred stage of the firingcycle, and preferably after energy is stored in the firing system, therelease latch desirably releases the firing rod for moving distally.

In one embodiment, the applicator instrument may include an advancercoupled with the actuator and extending through the elongated shaft foradvancing the surgical fasteners toward the distal end of the elongatedshaft. The advancer is preferably adapted to move toward the distal endof the elongated shaft as the actuator moves from the first position tothe second position. The advancer is preferably adapted to move towardthe proximal end of the shaft as the actuator moves from the secondposition to the first position. The advancer desirably includes aplurality of advancer tabs projecting toward a distal end of theadvancer, whereby each advancer tab is adapted to engage one of thesurgical fasteners for urging the surgical fasteners toward the distalend of the elongated shaft.

In one embodiment, the surgical fasteners are disposed within theelongated shaft for being urged toward the distal end of the elongatedshaft by the advancer. In one embodiment, a most distal one of thesurgical fasteners is engageable by the staging assembly for aligningthe most distal one of the surgical fasteners with the distal end of thefiring rod. In one embodiment, the distal end of the firing rod includesan insertion fork having spaced tines that are adapted to engage themost distal one of the surgical fasteners.

In one embodiment, a surgical fastener includes a first leg having adistal end with a first insertion tip, a proximal end, and a firstinsertion tool seating surface located adjacent the first insertion tip.The surgical fastener preferably includes a second leg having a distalend with a second insertion tip, a proximal end, and a second insertiontool seating surface located adjacent the second insertion tip. Thesurgical fastener also desirably includes a bridge connecting theproximal ends of the first and second legs for forming a closed proximalend of the surgical fastener. In one embodiment, tines of an insertionfork are preferably seatable against the first and second insertion toolseating surfaces of the surgical fastener for applying an insertionforce upon the surgical fastener at a location that is closer to thedistal end of the surgical fastener than the proximal end of thesurgical fastener.

In one embodiment, an applicator instrument may include a lockout systemcoupled with the firing system for preventing operation of the firingsystem after all of the surgical fasteners have been dispensed. In oneembodiment, the lockout system locks an actuator or trigger in a closedposition after all of the surgical fasteners have been dispensed.

In one embodiment, an applicator instrument for dispensing surgicalfasteners includes a housing having a handle section and a trigger, andan elongated shaft for dispensing the surgical fasteners. The elongatedshaft includes a proximal end coupled with the housing and a distal endremote therefrom. The elongated shaft may include a surgical fastenerdelivery conduit extending therethrough for delivering or dispensing thesurgical fasteners from the distal end of the elongated shaft. Theapplicator instrument preferably includes a firing system actuatable bythe trigger, whereby the firing system includes a firing rod and anenergy storing assembly coupled with the firing rod. In one embodiment,the firing system desirably has a firing cycle including a first stagefor moving the firing rod toward the distal end of the elongated shaftat a first speed and a second stage for transferring energy from theenergy storing assembly to the firing rod for driving the firing rodtoward the distal end of the elongated shaft at a second speed that isgreater than the first speed. In one embodiment, energy may be stored inthe energy storing assembly during the initial piloting stage when thefiring rod moves forward at the first speed.

In one embodiment, the applicator instrument may include a stagingassembly disposed within the elongated shaft for aligning the surgicalfasteners with a distal end of the firing rod. The surgical fastenersare preferably advanced through an elongated conduit in the elongatedshaft and toward the distal end of the elongated shaft. The applicatorinstrument may include an advancer coupled with the firing system forincrementally advancing the surgical fasteners toward the distal end ofthe elongated shaft each time the trigger is squeezed. In oneembodiment, the firing rod preferably moves distally as the trigger issqueezed from an open position to a closed position, and the firing rodmoves proximally as the trigger returns from the closed position to theopen position.

In one embodiment, a method of dispensing surgical fasteners includesproviding an applicator instrument having a housing, an elongated shaftprojecting from the housing, and a firing system including a firing rodfor dispensing surgical fasteners from a distal end of the elongatedshaft. The method preferably includes aligning a first surgical fastenerwith a distal end of the firing rod, advancing the distal end of thefiring rod toward the first surgical fastener at a first speed forengaging the surgical fastener, and after the firing rod advancing stepand while constraining the firing rod from moving toward the distal endof the elongated shaft, storing energy in the firing system. The methoddesirably includes releasing the firing rod for distal movement andtransferring the stored energy to the firing rod for driving the firingrod distally at a second speed that is greater than the first speed soas to dispense the first or lead surgical fastener from the distal endof the elongated shaft.

In one embodiment, the firing system desirably includes a compressiblefiring spring coupled with the firing rod, and an actuator coupled withthe firing spring for selectively compressing the firing spring forstoring energy in the firing system. In one embodiment, the energy foradvancing the firing rod is stored in a spring. In one embodiment, thespring is a firing spring that is preferably pre-loaded orpre-compressed prior to actuation of the applicator instrument.

In one embodiment, the applicator instrument includes a lockoutmechanism to prevent operation of the applicator instrument when no moresurgical fasteners are available (e.g. all of the surgical fastenershave been dispensed). In one embodiment, the lockout mechanismpreferably locks the trigger in a closed position when the device isempty. The lockout mechanism may also include a mechanical or electroniccounter that displays how many surgical fasteners have been dispensedand/or how many surgical fasteners remain available.

In one embodiment, the distal end of the applicator instrument, such asthe distal end of the elongated shaft, includes one or more markings fororientation. The distal end of the elongated shaft may also include oneor more features provided on the distal tip to assist with deviceorientation and/or to capture one or more mesh strands. In oneembodiment, the applicator instrument includes one or more protuberancesto capture one or more strands of mesh.

In one embodiment, a surgical fastener includes a first leg having adistal end, a proximal end and a first insertion tip at the distal endof the first leg. The surgical fastener preferably includes a second leghaving a distal end, a proximal end, and a second insertion tip at thedistal end of the second leg. A bridge desirably connects the proximalends of the first and second legs for forming a closed end of thesurgical fastener. The first insertion tip preferably includes a firstinsertion tool seating surface and the second insertion tip preferablyincludes a second insertion tool seating surface.

In one embodiment, the first and second legs extend along respectivelongitudinal axes, and the first and second insertion tips are skewed orangulated outwardly relative to the respective longitudinal axes of thefirst and second legs. As a result, in one embodiment, the spacingbetween the insertion tips is greater than the spacing between the firstand second legs, which may enhance the capture of strands or fibersbetween the legs. In one embodiment, at least one of the first andsecond insertion tips includes a blunt distal piercing point. In oneembodiment, both of the first and second insertion tips include bluntdistal piercing points.

In one embodiment, the first insertion tip includes a proximal end withthe first insertion tool seating surface, and the second insertion tipincludes a proximal end including the second insertion tool seatingsurface. In one embodiment, the first insertion tool seating surface iscloser to the distal end of the first leg than the proximal end of thefirst leg, and the second insertion tool seating surface is closer tothe distal end of the second leg than the proximal end of the secondleg. The first and second insertion tool seating surfaces preferablyface toward the proximal ends of the respective first and second legsand are adapted to be engaged by the distal end of an insertion tool,such as the distal ends of tines or an insertion fork.

In one embodiment, the first insertion tool seating surface includes anopening facing toward the proximal end of the first leg, and the secondinsertion tool seating surface includes a second opening facing towardthe proximal end of the second leg. The openings in the insertion toolseating surfaces may be blind openings that are closed at one end (e.g.at the distal end). In one embodiment, the first insertion tool seatingsurface includes a first aperture that extends completely through thefirst insertion tip, and the second insertion tool seating surfaceincludes a second aperture that extends completely through the secondinsertion tip.

In one embodiment, the first leg of a surgical fastener preferablyincludes a first alignment guide extending between the proximal end ofthe first leg and the first insertion tool seating surface, and thesecond leg preferably includes a second alignment guide extendingbetween the proximal end of the second leg and the second insertion toolseating surface. The first alignment guide on the first leg ispreferably in substantial alignment with the first insertion toolseating surface, and the second alignment guide on the second leg ispreferably in substantial alignment with the second insertion toolseating surface. The first and second alignment guides may include ribsextending between the distal and proximal ends of the legs, groovesextending between the distal and proximal ends of the legs, or acombination of ribs and grooves.

In one embodiment, the first and second insertion tips have distal endsthat are staggered from one another, which may reduce the amount offorce required to anchor the surgical fastener in tissue. In oneembodiment, the bridge adjacent the proximal end of the surgicalfastener defines a third insertion tool seating surface engageable by asurface on an insertion tool.

In one embodiment, the first leg of a surgical fastener includes a firstbarb projecting toward the proximal end of the first leg, and the secondleg of the surgical fastener includes a second barb projecting towardthe proximal end of the second leg, whereby the first and second barbsare staggered from one another. In one embodiment, the first and secondbarbs on the respective first and second legs project outwardly awayfrom one another. In another embodiment, the first and second barbs onthe respective first and second legs project inwardly toward oneanother.

In one embodiment, a surgical fastener for anchoring prosthetic devicesto tissue includes a first leg having a distal end, a proximal end, afirst alignment guide extending between the distal and proximal ends ofthe first leg, and a first insertion tip at the distal end of the firstleg. The surgical fastener desirably includes a second leg having adistal end, a proximal end, a second alignment guide extending betweenthe distal and proximal ends of the second leg, and a second insertiontip at the distal end of the second leg. The surgical fastenerpreferably includes a bridge connecting the proximal ends of the firstand second legs for forming a closed end of the surgical fastener.

In one embodiment, the first insertion tip has a proximal end with afirst insertion tool seating surface and the second insertion tip has aproximal end with a second insertion tool seating surface. The first andsecond insertion tool seating surfaces may include convex surfacesfacing toward the proximal ends of the first and second legs, concavesurfaces facing toward the proximal ends of the first and second legs,openings facing toward the proximal ends of the first and second legs,blind vias facing toward the proximal ends of the first and second legs,and/or apertures extending through the first and second insertion tips.

In one embodiment, the first and second alignment guides are selectedfrom the group of alignment guides including ribs extending between thedistal and proximal ends of the legs, and grooves extending between thedistal and proximal ends of the legs. The first and second alignmentguides are substantially aligned with the respective first and secondinsertion tool seating surfaces. In one embodiment, the first and secondseating surfaces are desirably closer to the distal end of the surgicalfastener than the proximal end of the surgical fastener.

In one embodiment, an applicator instrument for dispensing surgicalfasteners includes a housing, and an elongated shaft extending from thehousing, the elongated shaft having a proximal end, a distal end, and alongitudinal axis extending between the proximal and distal ends. Theapplicator instrument desirably includes a firing rod disposed insidethe elongated shaft and that is moveable within a first plane between aretracted position and an extended position. The elongated shaftpreferably includes an advancer disposed inside the elongated shaft thatis moveable within a second plane between a retracted position and anextended position. The applicator instrument preferably includes astaging assembly located adjacent the distal end of the elongated shaftthat is adapted to align surgical fasteners with a distal end of thefiring rod. The staging assembly is preferably held below the secondplane by the advancer when the advancer is in the extended position, andthe staging assembly is preferably adapted to move into at least partialalignment with the distal end of the firing rod when the advancer movestoward or is in the retracted position.

The applicator instrument preferably includes a plurality of surgicalfasteners disposed within the elongated shaft, whereby the advancer isadapted to move the surgical fasteners one position toward the distalend of the elongated shaft each time the advancer moves from theretracted position to the extended position. In one embodiment, theplurality of surgical fasteners desirably include a lead surgicalfastener located adjacent the distal end of the elongated shaft and aseries of trailing surgical fasteners located between the lead surgicalfastener and the proximal end of the elongated shaft.

In one embodiment, the advancer includes a plurality of advancer tabswhereby each of the advancer tabs is preferably adapted to engage one ofthe surgical fasteners for urging the surgical fasteners toward thedistal end of the elongated shaft as the advancer moves from theretracted position to the extended position. In one embodiment, theadvancer tabs project toward the distal end of the elongated shaft. Inone embodiment, the advancer is moveable into the extending position formoving the lead surgical fastener into contact with the stagingassembly.

In one embodiment, a floor of the elongated shaft includes a pluralityof anti-backup tabs, whereby the anti-backup tabs are adapted to preventthe surgical fasteners in the elongated shaft from moving toward theproximal end of the elongated shaft. In one embodiment, the anti-backuptabs project toward the distal end of the elongated shaft.

In one embodiment, the advancer urges the lead surgical fastener intocontact with the staging assembly, and the staging assembly is adaptedto lift the lead surgical fastener into substantial alignment with thedistal end of the firing rod as the advancer returns to the retractedposition.

In one embodiment, the elongated shaft includes at least one guidesurface adapted to engage and/or contact the firing rod for guidingdistal and proximal movement of the firing rod. In one embodiment, theat least one guide surface includes a pair of opposing guide flangesadapted to engage opposites sides of the firing rod for guiding distaland proximal movement of the firing rod.

In one embodiment, the distal end of the firing rod includes aninsertion tool, such as an insertion fork, having a first tine with adistal end adapted to engage the first insertion tool seating surface,and a second tine having a distal end adapted to engage the secondinsertion tool seating surface. In one embodiment, the bridge of thesurgical fastener has a proximal face defining a third insertion toolseating surface, and the insertion tool includes a distal surfaceextending between the proximal ends of the first and second tinesadapted to engage the third insertion tool seating surface.

In one embodiment, an applicator instrument for dispensing surgicalfasteners includes a housing, an elongated shaft extending from thehousing, the elongated shaft including a proximal end and a distal endremote therefrom, and a plurality of surgical fasteners disposed withinthe elongated shaft for being dispensed from the distal end of theelongated shaft. The applicator instrument preferably includes anadvancer disposed inside the elongated shaft that is moveable betweenthe proximal and distal ends of the elongated shaft, whereby theadvancer is adapted to shift the surgical fasteners one position closerto the distal end of the elongated shaft each time the advancer movesdistally. The applicator instrument preferably includes a firing roddisposed inside the elongated shaft and overlying the advancer, thefiring rod being moveable between the proximal and distal ends of theelongated shaft. The applicator instrument desirably includes a stagingassembly located adjacent the distal end of the elongated shaft that isadapted to receive a leading one of the surgical fasteners from theadvancer as the advancer moves distally and to shift the receivedleading surgical fastener into substantial alignment with a distal endof the firing rod when the advancer moves proximally.

In one embodiment, the distal end of the firing rod is adapted to movedistally at a first rate of speed for engaging the leading surgicalfastener, and then to move distally at a second rate of speed that isfaster than the first rate of speed for dispensing the leading surgicalfastener from the distal end of the elongated shaft.

In one embodiment, the first leg of the surgical fastener includes afirst alignment guide extending between the proximal end of the firstleg and the first insertion tool seating surface, and the second leg ofthe surgical fastener includes a second alignment guide extendingbetween the proximal end of the second leg and the second insertion toolseating surface. The first alignment guide on the first leg ispreferably in substantial alignment with the first insertion toolseating surface and the second alignment guide on the second leg ispreferably in substantial alignment with the second insertion toolseating surface. In one embodiment, the first alignment guide includes afirst rib extending between the distal and proximal ends of the firstleg, and the second alignment guide includes a second rib extendingbetween the distal and proximal ends of the second leg, whereby thefirst and second tines at the distal end of the firing rod have opposinginner surfaces with opposing grooves adapted to engage the first andsecond ribs on the respective first and second legs for engaging thesurgical fastener with the insertion tool.

In one embodiment, a method of dispensing a surgical fastener includesproviding an applicator instrument having a housing and an elongatedshaft extending from the housing, the elongated shaft including aproximal end and a distal end remote therefrom, and providing surgicalfasteners in the elongated shaft for being dispensed one at a time fromthe distal end of the elongated shaft. The method preferably includesadvancing the surgical fasteners within a first plane toward the distalend of the elongated shaft. After advancing a leading one of thesurgical fasteners to a location adjacent the distal end of theelongated shaft, the leading surgical fastener is preferably shiftedfrom the first plane into a second plane in which the leading surgicalfastener is substantially aligned with a distal end of a firing rod. Thefiring rod is then desirably moved distally for engaging the leadingsurgical fastener with the firing rod and dispensing the leadingsurgical fastener from the distal end of the elongated shaft.

In one embodiment, the method includes loading the surgical fasteners inthe elongated shaft. In one embodiment, the step of moving the firingrod distally includes a first distal movement stage during which thefiring rod moves distally at a first rate of speed for engaging theleading surgical fastener, and a second distal movement stage thatfollows the first distal movement stage during which the firing rodmoves distally at a second rate of speed for dispensing the leadingsurgical fastener from the distal end of the elongated shaft, wherebythe second rate of speed is greater than the first rate of speed.

In one embodiment, after the advancing step, and while constraining thefiring rod from moving toward the distal end of the elongated shaft,energy is stored in the firing system. The firing rod may later beunconstrained or released so that it is able to move in the distaldirection and the stored energy may be transferred to the firing rod fordriving the firing rod distally at the second speed that is greater thanthe first speed for dispensing the first surgical fastener from thedistal end of the elongated shaft.

In one embodiment, the firing system includes an energy storing elementsuch as a compressible firing spring coupled with the firing rod, and anactuator coupled with the firing spring for selectively compressing thefiring spring so as to store energy in the firing system.

In one embodiment, a method of affixing a prosthesis to tissue includesproviding an applicator instrument for dispensing surgical fastenershaving a housing, an elongated shaft extending from the housing, theelongated shaft having a proximal end coupled with the housing and adistal end remote therefrom, and a firing system for dispensing surgicalfasteners from the distal end of the elongated shaft. The firing systempreferably includes a firing rod disposed in the elongated shaft, thefiring system having a firing cycle with a first stage for advancing thefiring rod toward the distal end of the elongated shaft at a first rateof speed and a second stage for advancing the firing rod toward thedistal end of the elongated shaft at a second rate of speed that isgreater than the first rate of speed. The method preferably includespositioning a prosthesis, such as a surgical mesh, over tissue, andoperating the applicator instrument for dispensing at least one of thesurgical fasteners from the distal end of the elongated shaft foraffixing the prosthesis to the tissue. In one embodiment, a plurality ofsurgical fasteners may be dispensed for affixing the prosthesis to thetissue.

In one embodiment, a firing system for an applicator instrument adaptedto dispense surgical fasteners includes a housing, an elongated shaftextending from the housing, a firing rod disposed within the elongatedshaft, a firing rod release engageable with the firing rod forpreventing distal movement of the firing rod during at least one stageof a firing cycle, a trigger mounted to the housing, and a firing springhaving a first end connected with the firing rod and a second endadapted for being sequentially coupled and decoupled from the triggerduring the firing cycle. In one embodiment, the firing cycle desirablyincludes an initial stage in which the trigger is open and decoupledfrom the firing spring and the firing spring is at least partiallycompressed, and a piloting stage during which the firing rod release isdisengaged from the firing rod for enabling distal movement of thefiring rod. The trigger is preferably compressible a first distance forcoupling the trigger with the firing spring for moving the at leastpartially compressed firing spring distally, which, in turn, moves thefiring rod distally at a first rate of speed that is proportional to themovement of the trigger. In one embodiment, an energy storing elementsuch as a pneumatic or hydraulic device may be used in place of or incombination with the firing spring.

In one embodiment, the firing cycle includes, after the piloting stage,an energy storing stage in which the firing rod release engages thefiring rod for preventing distal movement of the firing rod, and thetrigger is further moveable a second distance for further compressingand storing energy in the firing spring. The firing cycle preferablyincludes a firing stage in which the firing rod release disengages fromthe firing rod so that the firing rod is free to move toward the distalend of the elongated shaft and the firing spring transfers the energystored therein to the firing rod for rapidly advancing the firing rodtoward the distal end of the elongated shaft at a second rate of speedthat is greater than both the first rate of speed and the movement ofthe trigger.

In one embodiment, the firing cycle includes a decoupling stage duringwhich the trigger is further compressible a third distance fordecoupling the trigger from the firing spring whereupon the firing rodis free to move toward the proximal end of the elongated shaft.

In one embodiment, the firing system includes an advancer disposedwithin the elongated shaft and that is moveable in proximal and distaldirections along the elongated shaft. The firing cycle preferablyincludes, after the firing stage, a surgical fastener advancing stageduring which the trigger is further compressible a fourth distance formoving the advancer toward the distal end of the elongated shaft so asto move the surgical fasteners toward the distal end of the elongatedshaft.

In one embodiment, the firing cycle preferably includes, after thesurgical fastener advancing stage, a retraction stage during which thetrigger moves from a compressed position to the open position of theinitial stage for moving the advancer in a proximal direction.

In one embodiment, the firing system preferably includes a spring blockdisposed within the housing and engageable with a proximal end of thefiring spring. The spring block is preferably adapted to move proximallyand distally along the longitudinal axis defined by the elongated shaft.In one embodiment, during the energy storing stage, the trigger iscoupled with the spring block for moving the spring block distally,which, in turn, further compresses the firing spring.

In one embodiment, the firing system includes a primary latch coupledwith the trigger. The primary latch is preferably adapted to couple thetrigger with the spring block during the piloting, energy storing, andfiring stages, and decouple the trigger from the spring block during thedecoupling, surgical fastener advancing, and retraction stages. In oneembodiment, at the beginning of the firing stage, the spring blockcontacts the firing rod release for disengaging the firing rod releasefrom the firing rod so that the firing rod may move distally.

In one embodiment, a firing system for a surgical fastener applicatorinstrument includes a housing and an elongated shaft extending from thehousing. The firing system desirably includes a firing rod disposedwithin the elongated shaft and being moveable proximally and distallyalong a longitudinal axis, a firing spring block disposed within thehousing and being adapted to move in proximal and distal directionsalong the longitudinal axis, and a firing spring having a distal endconnected with the firing rod and a proximal end engageable with thefiring spring block. The firing system preferably includes a triggermounted to the housing for driving the firing system, whereby thetrigger includes a primary latch for sequentially coupling anddecoupling the trigger from the firing spring block during a firingcycle.

In one embodiment, the firing cycle preferably includes an initial stagein which the trigger is open, the trigger is decoupled from the firingspring block, and the firing spring is at least partially compressed.The firing system preferably includes a piloting stage in which thefiring rod is free to move distally, and the trigger is compressible afirst distance for coupling the trigger with the firing spring block soas to move the at least partially compressed firing spring distally,which, in turn, moves the firing rod distally at a first rate of speedthat is proportional to the movement of the trigger. In one embodiment,the compression level of the firing spring remains unchanged during thepiloting stage. In one embodiment, the firing spring may be compressedduring the piloting stage.

In one embodiment, the firing cycle includes, after the piloting stage,an energy storing stage in which the trigger is further compressible asecond distance for further compressing and/or storing energy in thefiring spring while the firing rod release engages the firing rod forpreventing distal movement of the firing rod.

The firing cycle preferably includes, after the energy storing stage, afiring stage in which the firing rod release disengages from the firingrod so that the firing rod is free to move toward the distal end of theelongated shaft and the firing spring transfers the energy storedtherein to the firing rod for rapidly advancing the firing rod towardthe distal end of the elongated shaft at a second rate of speed that isgreater than the first rate of speed.

The firing cycle preferably includes, after the firing stage, adecoupling stage during which the trigger is further compressible athird distance for decoupling the trigger from the firing spring and thefiring rod so that said firing rod may move proximally.

In one embodiment, the firing system includes an advancer disposedwithin the elongated shaft. The advancer is preferably moveable betweenthe proximal and distal ends of the elongated shaft for moving surgicalfasteners toward the distal end of the elongated shaft. The firing cyclemay include, after the firing stage, a surgical fastener advancing stageduring which the trigger is further compressible a fourth distance formoving the advancer toward the distal end of the elongated shaft, which,in turn, moves the surgical fasteners toward the distal end of theelongated shaft.

In one embodiment, the firing system preferably includes a spring blockdisposed within the housing. The spring block is preferably adapted tomove proximally and distally along the longitudinal axis. The springblock preferably engages the firing spring, and during the energystoring stage, the trigger is coupled with the spring block for movingthe spring block distally, which, in turn, compresses the firing spring.The firing system may also include a primary latch coupled with thetrigger. The primary latch is preferably adapted to couple the triggerwith the spring block during the piloting, energy storing, and firingstages, and decouple the trigger from the spring block during thedecoupling, surgical fastener advancing, and retraction stages.

In one embodiment, a method of dispensing surgical fasteners from anapplicator instrument includes providing a housing, an elongated shaftextending from the housing, a firing rod disposed within the elongatedshaft that is moveable proximally and distally for dispensing surgicalfasteners from the distal end of the elongated shaft, a trigger foroperating the applicator instrument, and an energy storing elementdisposed between the trigger and the firing rod. The method preferablyincludes compressing the trigger for piloting the firing rod toward thedistal end of the elongated shaft at a first rate of speed, and afterpiloting the firing rod, preventing the firing rod from moving distallywhile further compressing the trigger for storing energy in the energystoring element. The method preferably includes releasing the firing rodfor distal movement, and transferring the energy stored in the energystoring element to the firing rod for moving the firing rod toward thedistal end of the elongated shaft at a second rate of speed that isgreater than the first rate of speed. In one embodiment, during thepiloting stage, the firing rod moves distally at a first rate of speedthat is proportional to the movement of the trigger.

In one embodiment, the energy storing element is a firing springdisposed between the trigger and the firing rod. In one embodiment, thefiring spring is at least partially compressed before piloting thefiring rod toward the distal end of the elongated shaft and the firingspring has a compression level that does not change during the pilotingstep. As noted herein, the energy storing element may also include apneumatic device, a hydraulic device, a compressed gas device, orcombinations thereof.

In one embodiment, the method includes providing a plurality of surgicalfasteners within the elongated shaft, and providing an advancer disposedwithin the elongated shaft. The advancer is preferably coupled with thetrigger and is adapted to move toward the distal end of the elongatedshaft when the trigger is compressed and move toward the proximal end ofthe elongated shaft when the trigger is opened. The method preferablyincludes compressing the trigger for moving the advancer toward thedistal end of the elongated shaft, whereby the distally moving advancershifts each of the surgical fasteners one position closer to the distalend of the elongated shaft. In one embodiment, the trigger may notreturn to the open position until it is completely squeezed to theclosed position.

The applicator instrument may be made in various lengths and diameters.Shorter lengths may be more suitable for open surgical procedures. Inone embodiment, the diameter of the shaft of the applicator instrumentis preferably between about 3-10 mm, and more preferably between about3-5 mm. In one embodiment, the applicator instrument includes more thanone surgical fastener and may be pre-loaded with a plurality offasteners such as 10, 25, 100 or more surgical fasteners. In oneembodiment, the applicator instrument is pre-loaded with 10 surgicalfasteners for open procedures. In one embodiment, the applicatorinstrument is pre-loaded with 30 surgical fasteners for standardlaparoscopic procedures. In one embodiment, the surgical fasteners maybe housed in cartridges for easy loading and/or re-loading. In certainembodiments, the applicator instrument may include a stay suture deviceas part of the handle, or a device/handle that dispenses a skin adhesivesuch as the tissue adhesive sold under the trademark Dermabond™ for usefor trocar wound closure.

In one embodiment, a surgical fastener preferably has a very smallprofile, may be semi-rigid, and may be fully resorbable. The resorbablenature of the surgical fastener preferably decreases chronic pain causedby permanent fixation. In addition, the low profile of the surgicalfastener reduces adhesions of the viscera. As is well known to thoseskilled in the art, it is very common to see excessive adhesions causedby permanent tackers during re-ops.

In one embodiment, a surgical fastener provides two points of fixationwith a connecting back span extending between the two points of fixationso as to spread the tissue holding forces over a greater area. The spanbetween the two points of fixation makes it possible to span the tackacross the edge of a mesh, which minimizes exposure of tissue to meshends that may be the source of tissue irritation.

In one embodiment, an applicator instrument deploys one or more softtissue surgical fasteners. The surgical fasteners provide low profilesoft tissue fixation of prosthetic materials onto the human body. In oneembodiment, the applicator instrument provides for tension-freelaparoscopic hernia repair using mesh. In one embodiment, a prostheticmesh is placed over an abdominal defect and attached to tissue witheither permanent or resorbable surgical fasteners. In one embodiment,the surgical fasteners are made of relatively soft materials such asplastic or absorbable polymers.

The present invention provides a number of benefits. In one embodiment,male features on a surgical fastener mate with female features on aninserter device, which reduces the cost for molding the surgicalfasteners. In one embodiment, pins or tines on an insertion deviceprovide rigidity during insertion of the surgical fastener and leavesless absorbable mass in tissue as compared with tack systems and methodsthat do not use inserter pins or tines for stiffening.

In one embodiment, the surgical fasteners have rounded proximal ends.Specifically, each surgical fastener has a connecting bridge or backspan at the proximal end of the surgical fastener that is rounded andresults in a very low profile after insertion into tissue. The lowprofile design and small diameter of the surgical fastener results inthe surgical fastener having the appearance of a suture stitch once thesurgical fastener is implanted. The lower profile also preferablyreduces the possibility of forming adhesions in the body.

In one embodiment, surgical fasteners have insertion pin holes orrecesses formed in the proximal portion of each insertion tip of thesurgical fasteners. The insertion pin holes or recesses are preferablylocated directly over the center of each insertion tip. As a result, theinsertion pin holes or recesses are substantially aligned with theinsertion tip to avoid tip bending and to direct forces for insertiondirectly behind each of the penetrating insertion tips.

In prior art fasteners having a single head, the single head may fallthrough the large pores of the prosthetic mesh. In one embodiment,surgical fasteners of the present invention have a connecting back spanor bridge between two insertion tips. The connecting back span or bridgemakes the surgical fastener more compatible for use with large poresurgical prosthetic meshes.

In one embodiment, surgical fasteners have blind holes that are filledby metal inserters, probes, or tines during application. The metalinserters preferably provide rigidity to the surgical fastener duringinsertion, allowing the surgical fastener itself to be made of a softermaterial, such as an absorbable polymer. In another embodiment, rigidinserters, probes or tines support the tips and/or legs of the surgicalfastener during anchoring into tissue.

In one embodiment, surgical fasteners have lead-in channels that arealigned with blind holes or tool seating surfaces. The lead-in channelsare axially open on at least one side, which enables less material to beused for forming the surgical fasteners, and which provides a space fortissue in-growth to maximize fixation strength.

In one embodiment, surgical fasteners have staggered tips, whichpreferably reduce the necessary penetration force by staggering the peakforces encountered during insertion. In one embodiment, surgicalfasteners have staggered barbs improve anchoring in tissue by requiringgreater pull out forces.

In one embodiment, surgical fasteners have barbs set out of plane fromeach other, which increase the force necessary for pull out of thesurgical fasteners. In one embodiment, surgical fasteners have insertiontips with through openings extending therethrough. The through openingsare preferably adapted to receive one or more needles forneedle-assisted insertion.

In one embodiment, surgical fasteners have one or more barbs with“living hinge” features. The living hinges enable the barbs to collapseeasily during insertion but flare outwardly during attempts to removethe surgical fasteners.

In one embodiment, the pointed insertion tips of the surgical fastenersare cut or have defined chisel points, which enable the insertion tipsto cut during insertion, thereby improving the ability of the surgicalfasteners to penetrate difficult materials such as GORE® dual mesh.Insertion tips having compound cut or chiseled angles may also be usedto allow for stronger, yet shorter tip designs.

In one embodiment, surgical fasteners may have conical-shaped insertiontips that create a puncture rather than a cut, thereby improving holdingforce. Although the present invention is not limited by any particulartheory of operation, it is believed that conical-shaped insertion tipscreate only a single point of stress concentration, whereby the sectionof the surgical fastener that follows must expand the hole radially. Itis believed that this may make it harder for the rest of the surgicalfastener to make it through the hole, but may potentially increaseretention forces by making a tighter hole.

In one embodiment, a surgical fastener includes a pair of spacedinsertion points having internally facing barbs. The internally facingbarbs desirably protect the barbs from external forces, and make thesurgical fasteners easier to multi-feed without damaging the barbs.These embodiments may have straight side walls and back spans thatenable the surgical fasteners to remain properly aligned within alaparoscopic tube.

In one embodiment, surgical fasteners may incorporate active agents suchanti-microbials and anti-adhesion materials. In one embodiment, surgicalfasteners may incorporate radio-opacity to enable the surgical fastenersto be visible on x-ray imaging machines.

In one embodiment, ribs are formed on the outside of each leg of thesurgical fastener, and an insertion fork has a mating channel thatstraddles each of the ribs. The ends of each fork tine bottom out inrecesses or seating surfaces formed in the insertion tips of thesurgical fastener. This above design transfers the complexity ofmanufacturing recesses from the legs of the surgical fastener to thetines of the insertion tool. This feature is especially importantbecause the applicator instrument will preferably dispense multiplesurgical fasteners (as opposed to just one insertion fork).

In one embodiment, an insertion tool includes a bridge that extendsbetween proximal ends of fork tines. The shape of the bridge on theinsertion tool may substantially conform to the proximal face of thebridge at the proximal end of the surgical fastener. In one embodiment,the insertion fork is designed so that the bridge element of theinsertion fork comes into contact with the proximal end of the surgicalfasteners at the time, or just prior to when, the distal ends of eachfork bottoms out or engages the seating surfaces formed in the insertiontips of the surgical fastener. In one embodiment, the bridge of theinsertion fork may include a softer (with respect to the durometer ofthe rest of the insertion fork) elastomeric material to reduce therequired dimensional precision necessary to assure contact of the bridgeand distal fork ends with the surgical fastener at about the same time.This configuration preferably enables the driving force behind thesurgical fastener to be distributed along a greater surface area of thesurgical fastener so as to reduce the pressure generated between theinsertion tool and the surgical fastener.

These and other preferred embodiments of the invention will be describedin more detail below.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A shows a perspective view of an applicator instrument fordispensing surgical fasteners, in accordance with one embodiment of thepresent invention.

FIG. 1B shows a left side view of the applicator instrument shown inFIG. 1A.

FIG. 1C shows a right side view of the applicator instrument shown inFIG. 1A.

FIG. 2 shows a cross sectional view of a proximal end of the applicatorinstrument shown in FIGS. 1A-1C, in accordance with one embodiment ofthe present invention.

FIG. 3A shows an exploded perspective view of a distal end of theapplicator instrument shown in FIGS. 1A-1C, in accordance with oneembodiment of the present invention.

FIG. 3B shows an exploded left side view of the distal end of theapplicator instrument shown in FIG. 3A.

FIGS. 4A-4E show a staging leaf assembly for the applicator instrumentshown in FIGS. 1A-1C, in accordance with one embodiment of the presentinvention.

FIG. 5A shows a perspective view of a distal end of an applicatorinstrument for dispensing surgical fasteners, in accordance with oneembodiment of the present invention.

FIG. 5B shows a side view of the distal end of the applicator instrumentshown in FIG. 5A.

FIG. 5C shows a top plan view of the distal end of the applicatorinstrument shown in FIGS. 5A and 5B.

FIG. 6 shows a perspective view of a distal end of an applicatorinstrument, in accordance with one embodiment of the present invention.

FIG. 7A shows a distal end of an applicator instrument including anouter tube, in accordance with one embodiment of the present invention.

FIG. 7B shows the distal end of the applicator instrument of FIG. 7Awith the outer tube removed.

FIG. 8A shows a perspective view of a surgical fastener, in accordancewith one embodiment of the present invention.

FIG. 8B shows a front view of the surgical fastener shown in FIG. 8A.

FIG. 8C shows a left side view of the surgical fastener shown in FIG. 8Aincluding an insertion tip.

FIG. 8C-1 shows an enlarged view of the insertion tip shown in FIG. 8C.

FIG. 8D shows a right side view of the surgical fastener shown in FIG.8A.

FIG. 8E shows a distal end view of the surgical fastener shown in FIG.8A.

FIG. 8F shows a proximal end view of the surgical fastener shown in FIG.8A.

FIG. 8G shows a cross-sectional view of one of the legs of the surgicalfastener shown in FIG. 8F.

FIG. 9A shows a perspective view of an insertion fork aligned with asurgical fastener, in accordance with one embodiment of the presentinvention.

FIG. 9B shows a top plan view of the insertion fork and the surgicalfastener shown in FIG. 9A.

FIG. 10A shows a distal end of an applicator instrument for dispensingsurgical fasteners, in accordance with one embodiment of the presentinvention.

FIG. 10B shows a side view of the distal end of the applicatorinstrument shown in FIG. 10A.

FIG. 100 shows a top plan view of the distal end of the applicatorinstrument shown in FIGS. 10A and 10B.

FIGS. 11A-11N show a cross-sectional view of a proximal end of anapplicator instrument during stages of a firing cycle, in accordancewith one embodiment of the present invention.

FIGS. 11A-1 through 11N-1 show a cross-sectional side view of a distalend of an applicator instrument during the stages of a firing cycleshown in respective FIGS. 11A-11N.

FIGS. 12A-12E show a method of using an applicator instrument fordispensing surgical fasteners for securing a prosthetic device totissue, in accordance with one embodiment of the present invention.

FIG. 13A shows a perspective view of a lockout system for an applicatorinstrument, in accordance with one embodiment of the present invention.

FIG. 13B shows a side view of the lockout system shown in FIG. 13A.

FIGS. 14A-14E show a top plan view of the lockout system of FIGS. 13Aand 13B, in accordance with one embodiment of the present invention.

FIGS. 15A-15E show other perspective views of the lockout system shownin FIGS. 13A-13B and 14A-14E, in accordance with one embodiment of thepresent invention.

FIGS. 16A-16B show a surgical fastener, in accordance with oneembodiment of the present invention.

FIGS. 17A-17C show a method of dispensing a surgical fastener using aninsertion tool, in accordance with one embodiment of the presentinvention.

FIGS. 18A-18B show a surgical fastener, in accordance with oneembodiment of the present invention.

FIGS. 19A-19C show a distal end of an insertion tool for implanting thesurgical fastener of FIGS. 18A-18B, in accordance with one embodiment ofthe present invention.

FIGS. 20A-200 show a method of implanting the surgical fastener of FIGS.18A-18B using the insertion tool of FIGS. 19A-19C, in accordance withone embodiment of the present invention.

FIG. 20B-1 shows an expanded view of the surgical fastener and thedistal end of the insertion tool shown in FIG. 20B.

FIGS. 21A-21B show a surgical fastener, in accordance with oneembodiment of the present invention.

FIGS. 22A-22C show an insertion tool for implanting the surgicalfastener of FIGS. 21A-21B, in accordance with one embodiment of thepresent invention.

FIG. 23 shows a perspective view of a surgical fastener having out ofplane barbs, in accordance with one embodiment of the present invention.

FIG. 24 shows a surgical fastener, in accordance with one embodiment ofthe present invention.

FIG. 25A shows a perspective view of a surgical fastener, in accordancewith one embodiment of the present invention.

FIG. 25B shows an insertion tool for deploying the surgical fastener ofFIG. 25A, in accordance with one embodiment of the present invention.

FIG. 26 shows a front view of a surgical fastener, in accordance withone embodiment of the present invention.

FIG. 27 shows a distal end of an applicator instrument for dispensingsurgical fasteners, in accordance with one embodiment of the presentinvention.

FIGS. 28A and 28B show a method of using the applicator instrument shownin FIG. 27 for dispensing a surgical fastener, in accordance with oneembodiment.

FIG. 29 shows a distal end of an applicator instrument for dispensingsurgical fasteners, in accordance with one embodiment of the presentinvention.

DETAILED DESCRIPTION

Referring to FIGS. 1A-1C, in one embodiment, an applicator instrument100 for dispensing surgical fasteners has a proximal end 102 and adistal end 104. The applicator instrument 100 includes a housing 106that contains a firing system for deploying the surgical fasteners. Thehousing 106 has a left cover 108 and a right cover 110. The left andright covers 108, 110 have lower ends forming a hand grip 112. Theapplicator instrument 100 preferably includes a trigger 114 that may besqueezed for dispensing the surgical fasteners from the distal end 104of the instrument. In one embodiment, the applicator instrument 100holds a plurality of surgical fasteners, whereby a single surgicalfastener is dispensed from the distal end 104 of the applicatorinstrument each time the trigger 114 is squeezed. In one embodiment, theapplicator instrument holds a plurality of surgical fasteners that areadvanced toward the distal end of the outer tube 116 each time thetrigger 114 is squeezed. The surgical fasteners preferably advance oneposition each time the trigger is squeezed.

In one embodiment, the applicator instrument 100 desirably includes anelongated outer shaft or tube 116 having a proximal end 118 coupled witha distal end of the housing 106 and a distal end 120 adapted to dispensethe surgical fasteners. The distal-most end of the elongated outer tube116 preferably has an end cap 122 secured thereto. The applicatorinstrument preferably has a longitudinal axis designated A-A thatextends between the proximal and distal ends 102, 104 thereof. The outertube 116 desirably extends along the longitudinal axis A-A.

Referring to FIG. 1A, in one embodiment, the housing 106 may include alockout indicator opening 124 that provides visual access to a lockoutindicator. In one embodiment, the applicator instrument initially holdsa plurality of surgical fasteners that are dispensed from the distal end120 of the outer tube 116. The lockout indicator preferably moves towarda lockout condition that occurs after all of the surgical fasteners havebeen dispensed. The lockout indicator opening 124 may provide anindication of how many surgical fasteners have been dispensed, how manysurgical fasteners remain in the applicator instrument, and/or when thelockout condition is reached.

Referring to FIG. 2, in one embodiment, the housing 106 preferablycontains a firing system for dispensing one or more surgical fastenersfrom the distal end of the instrument. As will be described in moredetail below, many of the components of the firing system move along thelongitudinal axis A-A, between the proximal and distal ends of theinstrument. The components generally move toward the distal end 104 asthe trigger 114 is pulled or squeezed and reverse direction to movetoward the proximal end as the trigger opens.

In FIG. 2, the left cover 108 (FIG. 1A) of the housing 106 has beenremoved to reveal at least some of the components of the firing system.In one embodiment, the firing system includes the trigger 114 having atrigger gear 126 coupled therewith. The trigger gear 126 preferablyincludes a trigger return projection 128 adapted to travel within atrigger guide path 129. The trigger return projection 128 is desirablycoupled with an upper end of a trigger return spring 130. In oneembodiment, the trigger return spring 130 is stretched as the trigger114 is squeezed for storing energy in the trigger return spring. Whenthe trigger is free to return to the open position, the trigger returnspring 130 preferably pulls the trigger return projection 128 toward theinitial position shown in FIG. 2. The firing system preferably includesa trigger dampening element 132 coupled with the trigger returnprojection 128 for dampening movement of the trigger 114 as itapproaches the ends of the trigger guide path 129. The trigger dampeningelement 132 may be made of a compliant material such as a polymer orrubber.

The trigger gear 126 includes trigger gear teeth 134 adapted to engage afirst set of teeth (not shown) provided on a drive gear 136. The drivegear 136 includes a second set of teeth 138 adapted to mesh with teeth140 providing on an underside of a yoke 142. The drive gear 136 isdriven by the trigger gear 126. As the trigger 114 is squeezed, thetrigger gear 126 rotates the drive gear 136 in a counter clockwisedirection. As the trigger 114 opens, the trigger gear 126 rotates thedrive gear 136 in a clockwise direction.

In one embodiment, the firing system includes a yoke 142 that is adaptedto move distally and proximally along the longitudinal axis A-A of theapplicator instrument. In one embodiment, the yoke 142 is directlycoupled to the trigger 114 through the trigger gear 126 and the drivegear 136. As the trigger 114 is squeezed to the closed trigger position,the trigger gear 126 and the drive gear 136 move the yoke 142 distally(to the left in FIG. 2). As the trigger 114 returns to the open triggerposition, the trigger gear 126 and the drive gear 136 move the yoke 142proximally (to the right in FIG. 2).

In one embodiment, the firing system preferably includes a ratchet pawl144 having a ratchet pawl projection 145 that engages teeth on anunderside of the yoke 142. The ratchet pawl is desirably coupled with aratchet pawl torsion spring 146. As will be described in more detailbelow, during at least one stage of a firing cycle, the ratchet pawl 144constrains the yoke 142 from changing direction until the trigger 114 iscompletely closed or completely open. In one embodiment, as the trigger114 is pulled, the yoke 142 is required to move distally beyond theprojection 145 on the ratchet pawl 144 before the yoke is able to changedirections and move proximally.

The firing system preferably includes a primary latch 150 that projectsfrom a distal end of the yoke 142. The primary latch 150 is connected tothe yoke 142 and moves simultaneously in distal and proximal directionswith the yoke. In one embodiment, the primary latch 150 is adapted tomove around a primary latch racetrack 152 formed in the housing 106 forsystematically coupling and de-coupling the yoke 142 from anothercomponent of the firing system, as will be described in more detailbelow. In one embodiment, as the yoke 142 moves distally, the primarylatch 150 preferably moves over the primary latch racetrack 152. As theyoke 142 moves proximally, the primary latch 150 preferably moves underthe primary latch racetrack 152.

The firing system preferably includes an indexer 154 that is adapted tomove in distal and proximal directions along the longitudinal axis A-Aof the applicator instrument. The indexer 154 includes a lower slot 156that is in communication with a boss 158 extending from a side of theyoke 142, hereinafter referred to as the yoke boss 158. The yoke boss158 is adapted to slide within the lower slot 156 of the indexer 154. Inone embodiment, when the yoke boss 158 reaches a distal end 160 of thelower slot 156 of the indexer, the yoke boss 158 urges the indexer 154to move toward the distal end of the applicator instrument 100. Theindexer 154 includes an upper slot 162 coupled with a lockout indicatorsystem, as will be described in more detail below.

In one embodiment, the indexer 154 is directly coupled to an advancer166 that is adapted to advance surgical fasteners toward the distal endof the applicator instrument. As the indexer 154 moves distally, theadvancer 166 moves simultaneously with the indexer toward the distal endof the applicator instrument. As the indexer moves proximally, theadvancer 166 moves simultaneously with the indexer toward the proximalend of the applicator instrument. In one embodiment, the advancer 166 isadapted to move the surgical fasteners toward the distal end of theapplicator instrument so that the surgical fasteners may be dispensedfrom the distal end of the instrument. In one embodiment, the surgicalfasteners are advanced one position each time the advancer movesproximally.

In one embodiment, the firing system desirably includes a spring block170 that is selectively coupled with the yoke 142 through the primarylatch 150. The spring block is preferably adapted to move distally andproximally along the longitudinal axis designated A-A. In oneembodiment, when the primary latch 150 is coupled with the spring block,the yoke and the spring block preferably move simultaneously with oneanother as a unit. When the primary latch 150 is de-coupled from thespring block 170, the yoke 142 and the spring block preferably moveindependently of one another.

In one embodiment, the firing system also preferably includes a firingspring 172 disposed within the spring block 170. The firing spring 172,which is pre-compressed within the spring block, desirably has a distalend coupled with a firing rod 174 and a proximal end that engages aproximal end wall 171 of the spring block. In one embodiment, theproximal end of the firing rod 174 desirably has a cruciform-shapedcoupling 176 that is connected with the distal end of the firing spring172. One or more firing rod dampers 178 may be connected with thecruciform-shaped coupling 176 for dampening movement of the firing rod174 as it reaches the distal and/or proximal ends of its travel path.

In one embodiment, the firing system includes a firing spring releaselatch 180 that constrains distal movement of the firing rod. During onestage of a firing cycle, the firing spring release latch constrains thefiring rod from distal movement as energy is stored in the firing spring172. During a later stage of the firing cycle, the firing spring releaselatch releases the firing rod 174 for distal movement. As will bedescribed in more detail below, in one embodiment, the firing latch 180preferably engages an outer surface of the spring block 170. The outersurface of the spring block preferably urges the firing latch into arelease position so as to release the firing rod 174 for distalmovement.

In one embodiment, the firing system desirably includes a firing rodreturn spring 184 that engages the spring block 170 for returning thespring block 170 to the initial, proximal position shown in FIG. 2. Asthe spring block 170 moves distally (to the left), energy is stored inthe firing rod return spring 184. The energy is later released formoving the spring block proximally. At this stage, the firing rod maymove proximally with the spring block. The firing system also desirablyincludes one or more dampening springs 186 that are adapted to engageone or more components of the firing system for dampening movement ofthe components toward the ends of travel ranges. The dampening springspreferably minimize noise, vibration, violent movements, etc. duringfiring cycles.

Referring to FIG. 3A, in one embodiment, a distal end 104 of theapplicator instrument 100 is adapted to deliver surgical fasteners 232.The outer tube (FIG. 1A) that normally surrounds the components shown inFIG. 3A has been removed to more clearly show the internal components.In the particular embodiment shown in FIG. 3A, the internal componentsat the distal end 104 of the applicator instrument 100 have beenexploded for more clearly showing the parts and the operation of theapplicator instrument.

Referring to FIG. 3A, in one embodiment, the applicator instrument 100includes a ceiling stamping 200 having one or more ceiling stampingspring tabs 202 provided along the length thereof. The ceiling stamping200 preferably includes one or more ceiling stamping assembly notches204 formed in side walls thereof for facilitating assembly of theapplicator instrument. The ceiling stamping 200 preferably includes apair of opposed alignment guides that 206 that are adapted to guidedistal and proximal movement of the firing rod, as will be described inmore detail below.

The applicator instrument also preferably includes an anti-backupstamping 208 that is assembled with the ceiling stamping 200. Theanti-backup stamping 208 includes side walls having assembly tabs 210projecting therefrom. The assembly tabs 210 are adapted to be alignedwith the assembly grooves 204 on the ceiling stamping 200 to facilitateproper alignment and assembly of the ceiling stamping with theanti-backup stamping. The anti-backup stamping 208 desirably includesanti-backup tabs 212 provided along the length thereof. The anti-backuptabs preferably project toward the distal end of the applicatorinstrument and allow the surgical fasteners to move in only onedirection, namely distally. The anti-backup tabs 212 desirably constrainthe surgical fasteners from moving toward the proximal end of theapplicator instrument.

Referring to FIG. 3A, the anti-backup stamping 208 preferably includes astaging leaf opening 214 provided adjacent a distal end of theanti-backup stamping 208, and an aperture 216 proximal the staging leafopening 214 that is desirably used for securing a staging leaf assemblyto the anti-backup stamping 208, as will be described in more detailbelow.

The applicator instrument preferably includes the firing rod 174 havingan insertion fork 220 at a distal end thereof. The insertion fork 220has a proximal end 222 coupled with a distal end of the main section ofthe firing rod 174, and a distal end 224 adapted to engage the surgicalfasteners. The distal end of the application instrument also preferablyincludes the staging leaf assembly including a staging leaf support 226and a staging leaf 228. Proximal ends of the respective staging leafsupport 226 and the staging leaf 228 are aligned with the aperture 216in the anti-backup stamping 208.

The applicator instrument also preferably includes the advancer 166,which is adapted to advance surgical fasteners toward the distal end ofthe instrument. The advancer desirably has advancer tabs 230 adapted toengage the surgical fasteners for urging the surgical fasteners towardthe distal end of the application instrument. In one embodiment, theadvancer 166 advances the surgical fastener one position toward thedistal end of the applicator instrument each time the trigger issqueezed closed.

FIG. 3B shows an exploded side view of the distal end 104 of theapplicator instrument 100. The ceiling stamping 200 is adapted forassembly with the opposed anti-backup stamping 208. The assembly grooves204 on the ceiling stamping 200 are preferably aligned with the assemblytabs 210 on the anti-backup stamping 208. The firing rod 174 includingthe insertion fork 220, the advancer 166, the staging leaf support 226and the staging leaf spring 228 are preferably at least partiallydisposed between the ceiling stamping 200 and the anti-backup stamping208. After the components shown in FIG. 3B have been assembled together,the components are desirably disposed within the outer tube 116 shown inFIGS. 1A-1C. In one embodiment, the end cap 122 is desirably assembledwith distal-most ends of the outer tube 116, the ceiling stamping 200,and the anti-backup stamping 208. In one embodiment, the ceilingstamping spring tabs 202 preferably press against the inner surface ofthe outer tube for minimizing movement of the internal components withinthe outer tube.

Referring to FIG. 3B, in one embodiment, the advancer 166 includes aseries of advancer tabs 230 projecting from an underside of theadvancer. The advancer tabs 230 preferably project toward the distal endof the advancer 166. The advancer tabs 230 desirably engage surgicalfasteners 232 disposed within the outer tube for urging the surgicalfasteners toward the distal end of the applicator instrument. In oneembodiment, a plurality of surgical fasteners 232A-232D are desirablyprovided within the applicator instrument. Each time the trigger issqueezed, the advancer tabs 230 urge the surgical fasteners 232A-232Dtoward the distal end of the instrument for being dispensed from thedistal end of the instrument. When a trailing surgical fastener (e.g.the fastener designated 232B) is advanced sufficiently to become a leadsurgical fastener (e.g. the lead fastener designated 232A), it isadvanced into contact with the staging leaf 228, which is adapted tomove the lead surgical fastener 232A into alignment with tines at thedistal end of the insertion fork 220.

Referring to FIGS. 4A-4E, in one embodiment, the applicator instrumentincludes the staging leaf assembly located adjacent the distal end ofthe anti-backup stamping 208. Referring to FIG. 4A, in one embodiment,the anti-backup stamping 208 includes the anti-backup tabs 212projecting toward the distal end of the anti-backup stamping 208. Theanti-backup stamping 208 includes the staging leaf opening 214preferably disposed between the final anti-backup tab 212A and thedistal end of the anti-backup stamping 208. The anti-backup stamping 208also preferably includes the opening 216 proximal the staging leafopening 214. The aperture is preferably adapted to be aligned with aproximal end of the staging leaf support 226 and the staging leaf 228.

Referring to FIG. 4A, as noted above, the staging leaf assemblypreferably includes the staging leaf support 226 and the staging leaf228. The staging leaf support 226 has an opening 227 at a proximal endthereof that is desirably aligned with the opening 216 in theanti-backup stamping 208. The staging leaf 228 desirably includes adistal end having a staging leaf tab 229 and a proximal end including anopening 231 that is adapted to be aligned with the opening 216 in theanti-backup stamping and the opening 227 in the staging leaf support.The staging leaf 228 also includes a staging leaf anti-backup tab 233projecting toward the distal end of the staging leaf 228.

FIGS. 4B-4E show how the staging leaf support 226 and the staging leaf228 are assembled with the anti-backup stamping 208. As shown in FIGS.4B and 4C, in one embodiment, the staging leaf 228 is positioned overthe staging leaf support 226 and the proximal ends of the assembledcomponents are passed through the staging leaf opening 214 so that theopenings 227, 231 at the proximal ends of the staging leaf support 226and the staging leaf 228 are aligned with the opening 216 in theanti-backup stamping 208.

Referring to FIGS. 4D and 4E, the proximal ends of the staging leaf 228and the staging leaf support 226 underlie a bottom surface of theanti-backup stamping 208, and are preferably permanently connected tothe underside surface of the anti-backup stamping. The connection may bemade using a fastener, such as a screw, or other well-known connectingmethods such as welding. As shown in FIGS. 4D and 4E, the distal ends ofthe staging leaf 228 and the staging leaf support 226 extend through thestaging leaf opening 214, with the staging leaf tab 229 normallyprojecting above the anti-backup stamping 208.

Although the present invention is not limited by any particular theoryof operation, it is believed that the staging leaf assembly provides aspring-like device at the distal end of the anti-backup stamping forurging and/or moving a lead surgical fastener into alignment with thetines at the distal end of the insertion fork. The staging leaf assemblymay be deflected downwardly by the distal ends of the advancer and theinsertion fork when those components are extended toward the distal endof the applicator instrument. When the insertion fork and the advancerare retracted proximal to the staging leaf assembly, however, thestaging leaf assembly desirably springs upwardly to the position shownin FIGS. 4B-4E. As the staging leaf assembly springs upwardly, a leadsurgical fastener positioned atop the staging leaf assembly is movedinto alignment with the distal end of the insertion fork. In oneembodiment, the staging leaf tab 229 and the staging leaf anti-backuptab 233 stabilize the lead surgical fastener and hold the lead surgicalfastener in place as the insertion fork is advanced to secure the leadsurgical fastener.

Referring to FIGS. 5A-5C, in one embodiment, the ceiling stamping 200 isassembled with the anti-backup stamping 208. The ceiling stamping 200includes at least one assembly groove 204 that is aligned with at leastone assembly tab 210 on the anti-backup stamping 208 for ensuring properalignment of the stampings 200, 208 with one another. The distal-mostends of the ceiling stamping 200 and the anti-backup stamping 208 arepreferably held together by the end cap 122. In one embodiment, theceiling stamping has ceiling stamping spring tabs 202 that preferablyengage an inner surface of the outer tube (not shown) for enhancing thestability of the applicator instrument and preventing the ceilingstamping and the anti-backup stamping from moving relative to the outertube. In one embodiment, the end cap 122, and the distal-most ends ofthe ceiling stamping and the anti-backup stamping have one or moretongue and groove structures for assembling the end cap 122 with theceiling and anti-backup stampings 200, 208.

Referring to FIG. 6, in one embodiment, distal-most ends of the ceilingstamping 200 and the anti-backup stamping 208 are held together by theend cap 122. In one embodiment, the ceiling stamping 200 may include apair of guide flanges 206 that preferably conform to the side walls ofthe insertion fork 220 as the firing rod moves distally and proximally.In one embodiment, the guide flanges 206 preferably guide the distal andproximal movement of the insertion fork 220 to ensure proper alignmentof the tines of the insertion fork with the lead surgical fastener 232A.The applicator instrument 100 desirably includes the staging leafassembly including the staging leaf support 226 and the staging leaf228. As noted above, proximal ends of the staging leaf support 226 andthe staging leaf 228 are desirably coupled with the anti-backup stamping208. In one embodiment, the advancer 166 is desirably positioned betweenthe staging leaf assembly and the insertion fork 220. The advancer 166includes advancer tabs 230 that engage the surgical fasteners 232 foradvancing the surgical fasteners toward the distal end 104 of theapplicator instrument 100. Each time the advancer moves distally, theadvancer tabs preferably advance the surgical fasteners one positiontoward the distal end of the applicator instrument.

Referring to FIG. 7A, in one embodiment, the outer tube 116 is disposedaround the ceiling stamping 200 and the anti-backup stamping 208. InFIG. 7A, the outer tube 116 is transparent so that the ceiling stampingand the anti-backup stamping are visible. The end cap 122 is securedover the distal end of the outer tube 116 and includes assembly flangesthat are disposed between the outer tube 116, and the ceiling stampingand anti-backup stamping. The end cap 122 preferably engages the ceilingstamping 200 and the anti-backup stamping 208 so as to provide stabilityat the distal end of the applicator instrument 100. In one embodiment,the end cap 122 preferably includes castling 242 formed in a distal endface thereof. The castling 242 is adapted to engage surfaces (e.g. mesh)so as to prevent the distal end of the applicator instrument fromsliding or moving relative to the opposing surfaces. The castling 242may also be used for aligning the distal end of the applicatorinstrument with a prosthetic device, such as a prosthetic mesh. In oneembodiment, the castling may be used to align the distal end of theapplicator instrument with one or more strands on a prosthetic device.

FIG. 7B shows the distal end of the applicator instrument of FIG. 7Awith the outer tube 240 removed. The end cap 122 includes a top assemblyflange 244 that engages the ceiling stamping 200 and a bottom assemblyflange 246 that engages the anti-backup stamping 208. The top and bottomassembly flanges 244, 246 preferably hold the distal-most ends of theceiling stamping and the anti-backup stamping together for stabilizingthe distal end of the applicator instrument. The inner face of the endcap 122 preferably includes a pair of side assembly tabs 248A, 248B thatare disposed between the ceiling stamping and the anti-backup stamping.The side assembly tabs 248A, 248B may also enhance stability of thedistal end of the applicator instrument.

Referring to FIGS. 8A-8F, in one embodiment, the applicator instrumentdispenses surgical fasteners from a distal end thereof. Referring toFIGS. 8A and 8B, in one embodiment, a surgical fastener 232 desirablyincludes a distal end 250 and a proximal end 252. The surgical fastener232 preferably includes a first leg 254 having a first tip 256 providedat a distal end of the first leg, and a second leg 258 having a secondtip 260 provided at a distal end of the second leg. In one embodiment,the cross-sectional dimension of each first and second leg diminisheswhen moving from the proximal ends toward the distal ends of the legs.The surgical fastener 232 preferably includes a bridge 262 adjacent theproximal end 252 of the surgical fastener that connects the proximalends of the first and second legs 254, 258. In one embodiment, thebridge may be positioned between the proximal and distal ends of thesurgical fastener so long as it interconnects the first and second legs.The surgical fastener 232 preferably includes at least one first barb264 projecting rearwardly from the first tip 256 and at least one secondbarb 266 projecting rearwardly from the second tip 260. Although onlyone barb is shown on each leg, other surgical fasteners may havemultiple barbs on each leg or tip. The first and second tips 256, 260may be conical in shape. The respective tips may be formed with sharpleading points or may be more obtuse.

In one embodiment, the first and second tips 256, 260 have skewed distalpiercing tips or insertion tips that are skewed with respect tolongitudinal axes of the respective first and second legs 254, 258. Inone embodiment, the distal piercing tips are skewed outwardly withrespect to the longitudinal axes of the first and second legs. In oneembodiment, the distance between the tips is greater than the distancebetween the legs for increasing the likelihood of fibers of a prostheticdevice being captured between the legs. In one embodiment, the first andsecond tips 256, 260 have blunt distal piercing points. The blunt pointsenable the surgical fastener to penetrate tissue while minimizingunwanted penetration into the hand of an operator.

Referring to FIG. 8B, in one embodiment, the bridge 262 preferablyincludes a concave inner surface 268 facing toward the distal end 250 ofthe surgical fastener 232 and a convex outer surface 270 facing towardthe proximal end 252 of the surgical fastener. The first leg 254 has anouter wall having a first rib 272 that extends along a longitudinal axisA₁ of the first leg. The second leg 258 includes an outer wall having asecond rib 274 that extends along the longitudinal axis A₂ of the secondleg. In one embodiment, the distance D₁ between the piercing points atthe distal ends of the first and second tips 256, 260 is preferablygreater than the distance D₂ between the opposing surfaces of the firstand second legs 254, 256. The wider relative distance between the distalpiercing points of the first and second tips 256, 260 preferably ensuresthat the surgical fastener will engage strands on a porous prostheticdevice, such as the strands of a surgical mesh. In one embodiment, theoutwardly skewed distal piercing tips provides increased capacity tocapture surgical mesh fibers where the mesh fibers are separated fromone another without the need to increase the span between each leg.

Referring to FIG. 8C, in one embodiment, the first leg 254 has the firstrib 272 extending along the longitudinal axis A₁ of the first leg. Whenviewed from the side as shown in FIG. 8C, the first rib 272 ispreferably in substantial alignment with a distal point of the firstpiercing tip 256.

FIG. 8C-1 shows an enlarged view of the first piercing or insertion tip256 including a blunt piercing point 257. In one embodiment, the bluntpiercing point 257 enables the distal end of the surgical fastener topenetrate tissue while minimizing unwanted penetration into the hand ofan operator.

Referring to FIG. 8D, in one embodiment, the second leg 258 has thesecond rib 274 extending along the longitudinal axis A₂ of the secondleg 258. When viewed from the side as shown in FIG. 8D, the second rib274 is preferably aligned with a distal point of the second tip 260.

Referring to FIG. 8E, in one embodiment, the first and second piercingtips 256, 260 are preferably skewed outwardly from a center of thesurgical fastener 232. In one embodiment, the first and second piercingtips 256, 260 are preferably asymmetrical and are configured to extendoutwardly from the center of the surgical fastener 232.

Referring to FIG. 8F, in one embodiment, the rear face of the firstinsertion tip 256 includes a first seating surface 280 adapted toreceive a distal end of a first tine of an insertion fork. The rear faceof the second tip 260 preferably includes a second seating surface 282adapted to receive a distal end of a second tine of the insertion fork.In one embodiment, the convex seating surfaces 280, 282 are preferablysubstantially aligned with the distal piercing points of the first andsecond piercing tips 256, 260. The distal ends of the tines of theinsertion fork may have surfaces that conform to the respective seatingsurfaces 280, 282.

Referring to FIG. 8G, in one embodiment, the first leg 254 has an innerface that is rounded and an outer face that is squared-off. Although thepresent invention is not limited by any particular theory of operation,it is believed that such a structure desirably increases the strength ofthe surgical fastener by increasing the section modulus. Providing legshaving a cross-section with an inner rounded-off surface and an outersquared-off surface also preferably increases the force required to pullthe surgical fastener out of tissue.

In one embodiment, the surgical fastener may be made of absorbableand/or non-absorbable materials. Preferred absorbable materials includePDS, PDS/lactide-glycolide blends, PLA, etc. In one embodiment, eachsurgical fastener is sized to fit inside of a 5 mm outer diameter tube(typically trocar cannula dimension). The surgical fastener isfabricated by molding, however, with small modifications, otherprocesses such as casting, stamping, and machining may be used. In oneembodiment, the surgical fasteners may be extruded into a general shape,and then formed.

Referring to FIGS. 9A and 9B, in one embodiment, the surgical fastener232 is aligned with the insertion fork 220 at the distal end of thefiring rod for being dispensed from the distal end of the applicatorinstrument. The insertion fork 220 includes a proximal end 222 adaptedfor connection with a distal end of a main section of a firing rod (notshown) and a distal end 224 adapted to engage one or more surfaces ofthe surgical fastener 232. In one embodiment, the distal end 224 of theinsertion fork 220 includes a first tine 290 having a first inner groove292 formed therein, and a second tine 294 having a second inner groove296 formed therein. In one embodiment, the inner grooves 292, 296preferably oppose one another and extend along axes that are parallelwith the longitudinal axis A-A of the applicator instrument. Inoperation, the opposing inner grooves 292, 296 of the first and secondtines 290, 294 are preferably adapted to slide over the ribs 272, 274 onthe first and second legs 254, 258 of the surgical fastener. Theengagement of the inner grooves 292, 296 with the ribs 272, 274preferably aligns the surgical fastener element 232 with the distal end224 of the insertion fork 220, and stabilizes the surgical fastenerduring implantation in tissue. In one embodiment, the distal-most tipsof the first and second tines 290, 294 are advanced until they abutagainst the convex seating surfaces 280, 282 provided at the distalsurfaces of the first and second tips 256, 260.

Although the present invention is not limited by any particular theoryof operation, it is believed that providing an insertion fork withgrooved tines that engage ribs on outer surfaces of the legs of asurgical fastener will enhance stability and control of the surgicalfastener when dispensing the surgical fastener from the distal end ofthe applicator instrument. In addition, the insertion force is providedcloser to the distal end of the surgical fastener and not only at theproximal end of the surgical fastener as is the case with prior artsystems. This feature (i.e. providing insertion force on the surgicalfastener near the distal end of the fastener) may enable smaller and/orlower profile surgical fasteners to be used.

Referring to FIG. 10A, in one embodiment, the staging leaf assemblyincludes a staging leaf support 226 and a staging leaf 228 adapted tolift a lead surgical fastener 232A into alignment with the tines at thedistal end 224 of the insertion fork 220. The staging leaf 228preferably includes a staging leaf tab 229 that may engage the innersurface of the bridge 262 of the surgical fastener 232. The ribs on thelegs of the surgical fastener are preferably aligned with the opposinginner grooves 292, 296 on the opposing tines 290, 294 of the insertionfork 220.

Referring to FIG. 10B, in one embodiment, the staging leaf 228 alignsthe ribs 272, 274 on the surgical fastener 232 with the inner grooves onthe tines 290, 294 of the insertion fork 220. The staging leaf tab 229preferably engages the bridge 262 of the surgical fastener 232 forstabilizing the surgical fastener 232 as the tines 290, 294 slide overthe ribs 272, 274.

FIG. 100 shows a top plan view of the applicator instrument with theinner groove 292 of the first tine 290 aligned with the first rib 272 onthe first leg 254 of the surgical fastener 232 and the inner groove 296on the second tine 294 aligned with the second rib 274 on the second leg258 of the surgical fastener. As the surgical fastener is heldstationary by the staging leaf 228, the firing rod including theinsertion fork 220 is advanced toward the surgical fastener until thedistal-most ends of the tines 290, 294 are seated against the convexseating surfaces located behind the first and second tips 256, 260.After the tines 290, 294 are seated against the convex seating surfaces,the insertion fork 220 is ready for further advancement toward thedistal end of the applicator instrument for dispensing the surgicalfastener 232 from the applicator instrument.

FIGS. 11A-11N show the firing system of the applicator instrument duringvarious stages of a firing cycle. FIGS. 11A-1 through 11N-1 show thedistal end of the applicator instrument during the same stages shown inrespective FIGS. 11A-11N. For example, FIG. 11A shows the firing systemat the start of a firing cycle with the trigger 114 fully open and thefiring rod 174 fully retracted. FIG. 11A-1 shows the distal end of theapplicator instrument at the same stage as shown in FIG. 11A. FIGS.11B-11N and FIGS. 11B-1 through 11N-1 follow the same pattern.

Referring to FIG. 11A, in one embodiment, in a first stage of a firingcycle, the trigger 114 is completely open and the trigger gearprojection 128 is at the lower end of the trigger guide 129. The yoke142, the indexer 154, the advancer 166, the spring block 170, and thefiring rod 174 are all fully retracted toward the proximal end of theapplicator instrument. At the first stage of the firing cycle shown inFIG. 11A, the primary latch 150 is in a neutral position and isde-coupled from the spring block 170. The firing spring 172 is disposedbetween a proximal end of the spring block 170 and the cruciform-shapedcoupling 176 at the proximal end of the firing rod 174. The firingspring 172 extending between the spring block 170 and the firing rod 174is desirably pre-compressed so that there is an initial distal force (tothe left) on the firing rod 174. The firing rod 174 and the advancer 166project from a distal end of the housing 106 and extend toward a distalend of the applicator instrument 100.

FIG. 11A-1 shows the distal end 104 of the applicator instrument 100 atthe first stage of the firing cycle shown in FIG. 11A. The outer tube,the ceiling stamping, and the anti-backup stamping have been removedfrom the drawing figure to more clearly show the other internalcomponents disposed at the distal end of the applicator instrument.Referring to FIG. 11A-1, the staging leaf support 226 and the stagingleaf 228 desirably hold the lead surgical fastener 232A so that the ribs272, 274 on the outer side walls of the surgical fastener are inalignment with the inner grooves formed in the times 290, 294 at thedistal end 224 of the insertion fork 220. The staging leaf tab 129preferably stabilizes the lead surgical fastener 232A from furtherdistal movement. Additional trailing surgical fasteners 232B, 232C, 232Dare positioned behind the lead surgical fastener 232A. Although onlyfour surgical fasteners 232A-232D are shown in FIG. 10A-1, theapplicator instrument may carry additional surgical fasteners such as10, 25, 100 or more surgical fasteners. The advancer 166 includesadvancer tabs 230 that are adapted to push the respective surgicalfasteners 232B-232D toward the staging leaf assembly at the distal end104 of the applicator instrument 100. Each time the advancer 166 movesto the left, the surgical fasteners are advanced one position toward thedistal end 104 of the applicator instrument 100.

FIG. 11B shows a later stage of the firing cycle during which the tinesat the distal end of the insertion fork are piloted into engagement withthe ribs on the legs of the lead surgical fastener. During this stage ofthe firing cycle, the trigger 114 is partially squeezed toward the grip112 for moving the trigger gear 126 and the trigger gear projection 128toward the upper end of the trigger guide 129. As the trigger 114 ispulled, the trigger return spring 130 connected to the trigger gearprojection 128 is stretched to store potential energy in the spring. Asthe trigger gear 126 pivots in an upward, counterclockwise direction,the teeth on the trigger gear 126 rotate the drive gear 136 in acounterclockwise direction. The second set of gear teeth 138 on theouter periphery of the drive gear 136 engage the teeth 140 extendingalong the bottom surface of the yoke 142 for moving the yoke 142 towardthe distal end of the applicator instrument (to the left). As the yoke142 moves toward the distal end of the applicator instrument, theprimary latch 150 slides over a top surface of the primary latch raceway152 for coupling the yoke with the spring block. Because the firingspring 172 is pre-compressed inside the spring block, the firing rodmoves distally as the yoke, the spring block and the firing rod movedistally as a unit. At this stage, the firing rod moves distally at arate that is proportional to movement of the trigger.

Referring to FIG. 11B, the yoke 142 is adapted to slide within thehousing 106 in distal and proximal directions along the longitudinalaxis of the applicator instrument designated A-A. As the yoke 142 movesdistally, the yoke boss 158 slides in a distal direction toward thedistal end 160 of the lower slot 156 of the indexer 154. As will bedescribed in more detail below, when the yoke boss 158 abuts against thedistal end 160 of the lower slot 156 of the indexer 154, the yoke boss158 will urge the indexer 154 to move distally.

FIG. 11B-1 shows the distal end 104 of the applicator instrument 100during the stage of the firing cycle shown in FIG. 11B. The prongs 290,294 at the distal end 224 of the insertion fork 220 are piloted intoengagement with the legs of the lead surgical fastener 232A. Theinsertion fork 220 preferably moves distally at a rate that isproportional to the rate of the trigger squeeze. The staging leaf tab229 and the staging leaf 228 preferably stabilize the lead surgicalfastener 232A as the fork tines 290, 294 are piloted into engagementwith the ribs of the lead surgical fastener. The staging leaf tab 229may engage the inner surface of the outer tube to provide stability.

FIG. 11C shows the firing system after the insertion fork has beenpiloted onto the legs of the surgical fastener. In FIG. 11C, the distalend of the firing system is to the right and the proximal end of thefiring system is to the left. At about the same time or after theinsertion fork has been piloted distally for engaging the lead surgicalfastener, a firing spring latch 180 engages the cruciform-shaped end 176of the firing rod 174. Upon the engagement, the firing spring latch 180prevents further distal movement of the firing rod 174. Up to this pointin time, the firing rod has moved as a unit with the spring block 170,due to the pre-load on the firing spring within the spring block. Oncethe firing spring latch 180 engages the cruciform-shaped end 176, thefiring rod cannot continue to move distally. As a user continues tosqueeze the trigger 114, the firing rod 174 cannot move further distallyand the firing spring is compressed.

FIG. 11C-1 shows the distal end 104 of the applicator instrument 100during the stage shown in FIG. 11C. After the distal end of theinsertion fork 220 has been advanced into contact with the lead surgicalfastener 232A, the firing spring latch 180 holds the firing rod 174 fromfurther distal movement. Thus, after the distal end of the insertionfork has been piloted into contact with the lead surgical fastener, anduntil the applicator instrument “fires” the surgical fastener from thedistal end, the firing rod does not have any further distal movement asthe trigger continues to be pulled toward the fully closed position forstoring potential energy in the firing spring.

FIG. 11D shows a top cross-sectional view of a portion of the firingsystem during the same stage of the firing cycle shown in FIG. 11C. Thefiring system includes the firing rod 174, the cruciform-shapedstructure 176 at the proximal end of the firing rod 174, the firingspring 172 and the spring block 170 containing the firing spring 172. InFIG. 11D, the distal end of the applicator instrument is to the left andthe proximal end of the applicator instrument is to the right. As shownin FIG. 11D, as the trigger is pulled, the spring block 172 is urgedtoward the distal end of the applicator instrument by the primary latch(not shown). Distal movement of the spring block 170 compresses thefiring spring 172 between the cruciform-shaped structure 176 at theproximal end of the firing rod 174 and the proximal end of the springblock 170. As noted above, during this stage, the firing rod 174 isconstrained from further distal movement by the firing spring latch 180engaging the cruciform-shaped structure 176 of the firing rod 174. FIG.11D-1 shows the distal end 104 of the applicator instrument during thestage shown in FIG. 11D. As noted above, although the tines of theinsertion fork 220 have been piloted around the sides of the leadsurgical fastener 232A, the firing spring latch prevents further distalmovement of the firing rod 174 and the insertion fork 220.

FIG. 11E shows the firing system during a later stage of the firingcycle. The user preferably continues to squeeze the trigger 114 towardthe closed position. During this stage, the yoke 142 moves furtherdistally until the yoke boss 158 engages the distal end 160 of the lowerslot 156 of the indexer 154. Once the yoke boss 158 contacts the distalend 160 of the lower slot 156, further distal movement of the yoke 142urges the indexer 154 in a distal direction, which, in turn, urges theadvancer 166 to move distally for advancing surgical fasteners. Theindexer and the advancer preferably move together as a unit.

As the user continues to squeeze the trigger 114, the yoke 142 continuesto move distally, taking the spring block 170 with it in a distaldirection via the coupling of the primary latch 150 with the springblock 170. The firing rod 174 continues to be held back from furtherdistal movement by the firing rod latch (FIG. 11D). As the spring block170 moves distally, additional energy is stored in the firing spring 172disposed within the spring block. Because it has been compressed, thefiring spring is shorter than its original length with its right sidedisposed inside the proximal end of the spring block 170. As the springblock 170 moves distally (to the left), the spring block return spring184 is compressed. In one embodiment, a flange extending from the springblock 170 engages the spring block return spring 184 for storing energyin the spring block return spring.

FIG. 11E-1 shows the distal end 104 of the applicator instrument 100during the stage shown in FIG. 11E. As the indexer 154 (FIG. 11E) ismoved distally by the yoke boss 158, the indexer 154 urges the advancer166 to move in a distal direction, which advances the trailing surgicalfasteners 232B, 232C and 232D toward the distal end of the applicatorinstrument. There is no further distal movement of the lead surgicalfastener 232A at this stage.

FIG. 11F shows a top cross-sectional view of the firing system at alater stage of the firing cycle that occurs just before the firing rod174 is released. In one embodiment, the spring block 170 includes afiring spring release ramp 175 projecting from a surface thereof. Thefiring spring release ramp 175 is preferably aligned with the firingspring release latch 180. As the spring block 170 moves toward thedistal end of the applicator instrument (to the left), the ramp 175engages the firing spring release latch 180 for de-coupling the releaselatch 180 from the cruciform-shaped end 176 at the proximal end of thefiring rod 174. Once the release latch is de-coupled from thecruciform-shaped end 176 of the firing rod, the firing rod 174 is freeto move distally. The energy stored in the firing spring 172 is nowreleased to the firing rod 174.

FIG. 11F-1 shows the distal end 104 of the applicator instrument 100during the stage of the firing cycle shown in FIG. 11F. During thisstage, the firing spring release latch 180 is about to be released fromengagement with the cruciform-shaped end 176 of the firing rod. Theadvancer 166 has moved distally for advancing the trailing surgicalfasteners 232B-232D toward the distal end 104 of the applicatorinstrument 100.

FIG. 11G shows a later stage of the firing cycle during which the firingrod is released for rapidly advancing the insertion fork toward thedistal end of the applicator instrument. During this stage, the firingspring release ramp 175 pushes the firing spring release latch 180 awayfrom engagement with the cruciform-shaped structure 176. The firing rod174, unconstrained from distal movement, is rapidly advanced toward thedistal end of the applicator instrument by the firing spring 172. Thefiring spring 172 moves the firing rod 174 distally until the firing roddampening pad 178 engages a stop wall SW in the housing. The firing roddampening pad 178 may be compressed slightly until the positive stop 179on the cruciform-shaped structure 176 engages the stop wall SW forhalting all further distal movement of the firing rod. Although thepresent invention is not limited by any particular theory of operation,it is believed that the firing rod dampening pad 176 lengthens the timeperiod for deceleration of the firing rod 174 so as to stop the firingrod over a longer period of time. The lengthening of the decelerationperiod of the firing rod preferably decreases the impact forcetransmitted to a user, and also desirably reduces noise.

FIG. 11G-1 shows the distal end 104 of the applicator instrument duringthe stage of the firing cycle shown in FIG. 11G. The firing rod 174 andthe insertion fork 220 have been rapidly advanced distally (to the left)by the firing spring. The lead surgical fastener 232A is shot from thedistal end 104 of the applicator instrument 100 for securing aprosthetic device (e.g. a mesh) to tissue. As shown in FIG. 11G-1, at adistal-most position, the distal end 224 of the insertion fork 220 hasadvanced beyond the distal end of the end cap 122.

Referring to FIGS. 11G and 11G-1, the engagement of the positive stop179 with the stop wall SW (FIG. 11G) limits further distal movement ofthe insertion fork 220. Thus, the combination of the firing roddampening pad 178, the positive stop 179 and the stop wall SW limit themaximum expulsion of the lead surgical fastener 232A and the insertionfork from the applicator instrument. It has been observed that excessiveexpulsion of a surgical fastener and/or insertion fork from a distal endof an applicator instrument may damage a prosthetic device or injuretissue. In one embodiment, during the stage of the firing cycle shown inFIGS. 11G and 11G-1, the trailing surgical fasteners 232B-232D do notmove distally.

Referring to FIG. 11H, in one embodiment, after the lead surgicalfastener 232A has been dispensed, the firing cycle is not complete andthe trigger cannot return to the fully open position shown in FIG. 11A.In one embodiment, during this stage of the firing cycle, the trigger114 must be further squeezed for advancing the yoke 142 further towardthe distal end of the applicator instrument. In one embodiment, theratchet pawl 144 engaging the teeth on the underside of the yoke 142prevents the yoke 142 from changing direction to move proximally untilthe projection 145 on the ratchet pawl 144 clears the proximal end ofthe yoke 142. If an operator stops pulling the trigger before theprojection 145 on the ratchet pawl 144 clears the proximal end of theyoke 142, the trigger 114 freezes in position and will not return to thefully open position. Thus, an operator must continue to pull thetrigger, which continues to move the yoke toward the distal end of theapplicator instrument. As the yoke 142 continues to move distally, theyoke boss 158 moves the indexer 154 distally, which results in distalmovement of the advancer 166 for advancing the surgical fasteners. Asthe indexer moves distally, the upper slot 162 of the indexer 154 alsopreferably engages a tab 163 on the lockout counter 164 for at leastpartially rotating a lockout indicator, as will be described in moredetail below.

Referring to FIG. 11H, as the yoke 142 moves distally, the primary latch150 approaches a distal opening in the primary latch raceway 152. Oncethe primary latch 150 reaches the distal opening of the primary latchraceway 152, the primary latch 150 is free to drop for de-coupling theyoke 142 from the spring block 170. After de-coupling, the spring block170 is free to move independently of the yoke. In one embodiment, thede-coupled spring block will move toward the proximal end of theapplicator instrument in response to forces provided by the spring blockreturn spring 184.

FIG. 11H-1 shows the distal end 104 of the applicator instrument 100during the stage of the firing cycle shown in FIG. 11H. The insertionfork 220 cannot move further distally due to the stop wall SW in thehandle engaging the positive stop on the cruciform-shaped end of thefiring rod. Further distal movement of the yoke 142, however, continuesto move the indexer 154 to the left, which, in turn, moves the advancer166 in a distal direction to advance the trailing surgical fasteners232B, 232C and 232D toward the distal end 104 of the applicatorinstrument 100.

FIG. 111 shows the primary latch 150 after it has reached the distalopening in the primary latch racetrack 152. Once the primary latch 150reaches the distal opening, the primary latch 150 is free to drop forde-coupling the yoke 152 from the spring block 170. Once the primarylatch 150 de-couples the yoke 142 from the spring block 170, the springblock 170 and the yoke 152 move independently of one another. Referringto FIG. 111, as noted above, the yoke 152 is constrained from proximalmovement until the projection 145 on the ratchet pawl 146 clears theright end of the yoke 152.

FIG. 111-1 shows the distal end 104 of the applicator instrument 100after the primary latch 150 has been de-coupled from the spring block170. As the trigger continues to be compressed, the advancer 166continues to move distally for advancing the surgical fasteners 232B,232C and 232D in a distal direction.

Referring to FIG. 11J, as the trigger 114 continues to be compressed,the yoke 142 continues to advance the indexer 154 distally. Furtherdistal movement of the indexer 154 moves the advancer 166 distally andmoves the tab 163 on the lockout counter 164 distally. The tab 163 ofthe lockout counter 164 preferably frictionally engages the upper slot162 of the indexer 154. FIG. 11J-1 shows the distal end 104 of theapplicator instrument 100 during the stage of the firing cycle shown inFIG. 11J.

Referring to FIG. 11K, in one embodiment, after the primary latch 150has de-coupled from the spring block, the spring block return spring 184urges the spring block 170 to move proximally. As the spring block 170moves to the right, the spring block 170 pulls the firing rod 174 towardthe proximal end of the applicator instrument 100. Thus, the springblock 170 and the firing rod 174 move as a unit toward the proximal endof the applicator instrument while the yoke 142 continues to move towardthe distal end of the instrument under the force of the trigger 114. Inone embodiment, the yoke boss 158 continues to move the indexer 154distally for compressing the dampening spring 186. In one embodiment,the dampening spring 186 desirably gradually slows the user'scompression of the trigger when the indexer 154 pushes against it.

FIG. 11K-1 shows the distal end 104 of the applicator instrument 100during the stage shown in FIG. 11K. After the primary latch releases thespring block from the yoke, the spring block moves to the right, therebyretracting the firing rod 174 and the insertion fork 220. As shown inFIG. 11K-1, the lead surgical fastener 232A remains implanted in tissue,while the tines 290, 294 have been retracted from the ribs 272, 274 onthe lead surgical fastener.

Referring to FIG. 11L, once the trigger 114 is fully compressed, theright end of the yoke 142 clears the ratchet pawl 144. As a result, theyoke 142 is now free to move in a proximal direction. When the trigger114 is fully squeezed, the yoke boss 158 preferably urges the indexer154 into a distal-most position. In turn, the upper slot 162 of theindexer has preferably advanced the lockout counter 164 one-half of acycle. With the trigger in the fully compressed position, the triggerdampening pad 132 engages an end wall of the trigger guide 129 fordampening deceleration of the trigger.

FIG. 11L-1 shows the distal end 104 of the applicator instrument 100during the stage of the firing cycle shown in FIG. 11L. Distal movementof the indexer results in distal movement of the advancer 166. In oneembodiment, as the trigger is squeezed to the fully closed position, thesecond surgical fastener 232B is advanced to the lead surgical fastenerposition, the third surgical fastener 232C is advanced to the firsttrailing position, and the fourth surgical fastener 232D is advanced tothe second trailing position. In the stage of the firing cycle shown inFIG. 11L-1, the staging leaf 228 is preferably deflected downwardly bythe extended insertion fork 220 and the extended advancer 166. When thetrigger begins moving into the uncompressed, open position, the advancer166 and the insertion fork 220 are retracted, which enables the leadsurgical fastener 232B to be moved by the staging leaf 228 intoalignment with the tines of the insertion fork.

Referring to FIG. 11M, in one embodiment, as the trigger 114 rotatesback to the open, uncompressed position, the yoke 142 moves in aproximal direction. At this stage, the ratchet pawl 144 prevents theyoke 142 from changing direction until the yoke reaches a fullyretracted position. As the yoke 142 moves proximally, the primary latch150 moves below the primary latch racetrack 152.

FIG. 11M-1 shows the distal end 104 of the applicator instrument 100during the stage of the firing cycle shown in FIG. 11M. The new leadsurgical fastener 232B sits below the extended advancer 166 and thepartially extended insertion fork 220. The staging leaf 228 and thestaging leaf support 226 remain deflected in a downward position by theextended advancer and the extender insertion fork. The staging leaf 228is constrained from springing into an upright position due to beingblocked by the advancer 166 and the insertion fork 220.

Referring to FIG. 11N, in one embodiment, the spring block return spring184 returns the spring block 170 to its initial proximal position. Inturn, proximal movement of the spring block 150 retracts the firing rod174 and the insertion fork at the distal end of the applicatorinstrument. As the trigger moves to the fully open position, the yoke142 also reaches a proximal-most position. As the yoke 142 reaches theproximal end of its range, the primary latch 150 is urged upwardly by aprimary latch ramp 155 located adjacent a proximal end of the housing106. With the yoke 142 in a retracted position, the ratchet pawl 144moves into a neutral position under the yoke 142. At this stage, theyoke 142 is free to move distally and will not be constrained fromdistal movement by the ratchet pawl 144.

FIG. 11N-1 shows the distal end 104 of the applicator instrument duringthe final stage of the firing cycle shown in FIG. 11N. As shown in FIG.11N-1, the advancer 166 and the insertion fork 220 are fully retracted,thereby enabling the staging leaf 228 to deflect upwardly for aligningthe lead surgical fastener 232B with the tines of the insertion fork220.

In one embodiment, the applicator instrument of the present inventionmay be used to repair of a defect, such as an inguinal hernia, locatedin inguinal tissue such as the inguinal floor. Generally, an inguinalhernia may be accessed through the iliacus muscle. As can be wellappreciated, a network of vessels and nerves exist in the area of atypical inguinal hernia, which requires a surgeon to conduct a herniarepair with great skill and caution. For instance, in the transverseabdominis aponeurosis, an internal ring permits gastric vessels and Vasdeferens to extend therethrough over an edge of inguinal ligament. Afemoral canal is located near the Cooper's ligament and containsexternal iliac vessels and inferior epigastric vessels.

In many cases, the edge of the inguinal ligament and the Cooper'sligament serve as anatomical landmarks and support structures forsupporting surgical fasteners such as those mentioned previously. Thearea containing the external iliac vessels and the Vas deferens may becommonly known as “the Triangle of Doom” to surgeons. Accordingly, caremust be taken when performing dissection, suturing or fastening withinthis area.

A prosthetic or a mesh patch may be placed over the inguinal hernia. Themesh patch may have any desired configuration, structure or material. Inone embodiment, the mesh patch may be made of PROLENE™ (a well-knownpolymer made of fibers) and preferably configured as mesh.

The mesh patch may be placed over the inguinal hernia for providing asufficient barrier to internal viscera (not shown) of the abdomen whichwould otherwise have a tendency to protrude through the inguinal herniaand cause the patient a great deal of pain and discomfort. After themesh patch has been placed onto the inguinal floor, the mesh patch isready for attachment to the inguinal floor.

Referring FIG. 12A-12D, in one embodiment, a distal end 104 of anapplicator instrument 100 is positioned over a prosthetic device 270 forsecuring a prosthetic device, such as a mesh patch, to tissue T. Theprosthetic device may be a surgical mesh having strands 272 extendingtherethrough. The tips of each surgical fastener are preferably spacedfrom one another to increase the chances that the surgical fastener willengage at least one of the strands 272. The distal end 104 of theinstrument 100 preferably includes an end cap 122 having castling 242that facilitates holding the instrument in place over the prostheticdevice 270.

Referring to FIG. 12A, the applicator instrument 100 preferably includesan outer tube 116 surrounding a ceiling stamping 200 and an anti-backupstamping 208. The end cap 122 is coupled with the outer tube 116, theceiling stamping 200 and the anti-backup stamping 208. The ceilingstamping desirably has one or more ceiling stamping spring tabs 202 forpressing against the inner surface of the outer tube 116 to provide asnug fit between the inner stampings 200, 208 and the outer tube 116.The applicator instrument includes the insertion fork 220 having tinesprojecting from the distal end thereof. One of the tines 294 has aninner groove 296 that extends along the longitudinal axis A-A of theapplicator instrument for engaging a rib on a leg of the surgicalfastener. The applicator instrument includes the staging leaf assemblyincluding the staging leaf support 226 and the staging leaf 228 forholding the surgical fasteners in alignment with the tines 294 of theinsertion fork 220.

The advancer 166 is preferably disposed between the insertion fork andthe anti-backup stamping. The advancer 166 includes advancer tabs 230for urging the surgical fasteners toward the distal end of theapplicator instrument. The anti-backup stamping has anti-backup tabs 212that prevent the surgical fasteners from moving proximally.

In FIG. 12A, the firing system is positioned at a first stage of afiring cycle. The insertion fork 220 and the advancer 166 are retractedand the staging leaf assembly holds the lead surgical fastener 232A inalignment with the at least one tine 294 of the insertion fork 220.

FIG. 12B shows a later stage of the firing cycle when the at least onetine 294 of the insertion fork has been piloted distally to engage theribs on the lead surgical fastener 232A. During piloting, the insertionfork 220 moves distally at a rate that is proportional to the rate thatthe trigger is squeezed. During piloting, the staging leaf tab 229 andthe staging leaf 228 stabilize and hold the lead surgical fastener 232Afrom further distal movement.

In FIG. 12C, after potential energy has been stored in the firingspring, the firing rod 174 is released for dispensing the lead surgicalfastener 232A from the applicator instrument 100. The firing rod drivesthe insertion fork 220, which, in turn, drives the lead surgicalfastener 232A through the prosthetic device for implanting the tips ofthe surgical fastener in the tissue T for anchoring the prostheticdevice to the tissue T. During implantation into tissue, the tines ofthe insertion fork preferably support the lead surgical fastener 232A toprevent the lead surgical fastener from bending or twisting. As theinsertion fork 220 and the firing rod 174 drive the lead surgicalfastener 232A into the prosthetic device and the tissue T, the trailingsurgical fastener 232B preferably remains stationary.

Referring to FIG. 12D, in one embodiment, during a later stage of thefiring cycle, the trigger is pulled further for advancing the advancer166 toward the distal end of the applicator instrument 100. The advancertab 230 on the advancer 166 preferably engages the trailing surgicalfastener 232B for moving the trailing surgical fastener 232B distally.During this stage, the firing rod is decoupled from the yoke so that theinsertion fork 220 is free to retract and disengage from the dispensedsurgical fastener 232A.

Referring to FIG. 12E, when the trigger is fully closed, the trailingsurgical fastener 232B has been advanced to a staging position by theadvancer 166. The staging leaf assembly is constrained from moving thesecond surgical fastener 232B into alignment with the tines at the endof the insertion fork 220 because it blocked from such movement by theextended advancer 166 and the at least partially extended insertion fork220.

During a later stage not shown in FIG. 12E, the trigger returns to theopen position and the advancer and the insertion fork move proximally tothe positions shown in FIG. 12A. When the advancer 166 and the insertionfork 220 are retracted to the initial position shown in FIG. 12A, thestaging leaf assembly is free to move the second surgical fastener 232Binto alignment with the at least one tine 294 of the insertion fork 220.The applicator instrument is now ready to commence a second firing cycleduring which the second surgical fastener 232B will be dispensed fromthe applicator instrument for being implanted in the prosthetic device270 and the tissue T.

In one embodiment, the applicator instrument includes a lockoutindicator system that locks the applicator instrument from furtherdeployment of surgical fasteners after all of the surgical fastenershave been dispensed. Referring to FIG. 13A, in one embodiment, thelockout indicator system preferably includes a lockout counter 364having a lockout counter boss 365. The lockout counter preferably movesin distal and proximal directions along the longitudinal axis A-A of theapplicator instrument. The lockout counter boss 365 is preferablyaligned with the upper slot 362 of the indexer 354 so that the upperslot 362 is capable of sliding over the lockout counter boss 365. In oneembodiment, the lockout counter boss 365 has an outer dimension adaptedto slide within the upper slot 362 of the indexer 154, however, there ispreferably frictional contact between the lockout counter boss 365 andthe upper slot 362 as the lockout counter boss moves through the upperslot 362.

In one embodiment, as the trigger of the applicator instrument ispulled, the yoke moves distally, which, in turn, moves the indexer 354distally (to the left). Referring to FIG. 13B, as the indexer 354 movesdistally, the upper slot 362 of the indexer 354 slides over the lockoutcounter boss 365 of the lockout counter 364. The frictional engagementbetween the upper slot 362 and the lockout counter boss 365 moves thelockout counter 364 distally, which, in turn, rotates the lockoutindicator 375 in a counterclockwise direction.

FIGS. 14A-E show a lockout indicator system, in accordance with oneembodiment of the invention. The components surrounding the lockoutindicator system have been removed to simplify the description of theembodiment. Referring to FIG. 14A, the lockout indicator systemdesirably includes the lockout counter 364 having the lockout counterboss 365. The lockout counter 364 includes a first tooth 380 adjacent aproximal end of the lockout counter and a second tooth 382 adjacent aleading of the lockout counter. As noted herein, the lockout counter 364is adapted to move distally and proximally along the longitudinal axisA-A of the applicator instrument.

The lockout indicator system includes a lockout indicator 375 having amain ledge 384 with an alignment notch 386 and a lockout notch 388. Thealignment notch 386 desirably is utilized for properly aligning thelockout indicator 375 during initial assembly of the lockout indicatorsystem. The lockout notch 388 provides a larger opening in the mainledge 384 that enables a lockout pin to drop therein for locking thefiring system.

In one embodiment, the lockout indicator system includes a lock-put pin390 having a lockout flange 392 that engages the main ledge 384 of thelockout indicator, and a lockout pin spring 394 that urges the lockoutpin 390 in a downward direction once the lockout flange 392 is alignedwith the lockout slot 388.

Referring FIG. 14B, as the indexer 354 moves toward the distal end ofthe applicator instrument (to the left in FIG. 14B), the upper slot 362moves the lockout counter boss 365 distally, which, in turn, moves thelockout counter 364 distally. As the lockout counter 364 moves distally,the first tooth 380 adjacent the proximal end of the lockout counter 364engages teeth on the underside of the lockout indicator 375. Theengagement of the first tooth 380 of the lockout counter 364 with theteeth on the underside of the lockout indicator 375 rotates the lockoutindicator in a counterclockwise direction designated R₁. As the lockoutindicator 375 rotates in a counterclockwise direction, the lockoutflange 392 slides over the main ledge 384 of the lockout counter 375. Aslong as the lockout flange 292 is in contact with the main ledge 384,the lockout pin cannot drop.

Referring to FIG. 14C, the indexer 354 continues to move distally untilthe trigger is completely compressed. As the indexer 354 moves to itsdistal-most position, the upper slot 362 continues to urge the lockoutcounter boss to move distally. When the indexer 354 has advanced to itsdistal-most position (FIG. 14C), the indexer 154 may move in a proximaldirection (to the right) as the trigger opens. As the indexer 354 movesproximally, the indexer will, in turn, move the lockout counter 364 in aproximal direction so that the second tooth 382 on the lockout counterengages the teeth on the underside of the lockout indicator 375. Thesecond tooth 382 on the lockout counter preferably further rotates thelockout counter 375 in a counterclockwise direction designated R₁.

In one embodiment, one complete firing cycle will result in the lockoutcounter 364 moving distally and then proximally. As the lockout countermoves distally to its distal-most position, the lockout counter 364 willrotate the lockout indicator 375 another about 1/58 of a rotation. Asthe lockout counter 364 moves to its proximal-most position, the lockoutcounter will again rotate the lockout indicator 375 about 1/58 of arotation. Thus, each complete firing cycle will result in the lockoutindicator 375 rotating about 1/29 of a rotation. Eventually, the lockoutindicator 375 will rotate completely so that the lockout flange 392 isaligned with the lockout slot 388 formed in the main ledge 384 of thelockout indicator. In other embodiments, the lockout indicator mayrotate more or less than the example provided below.

FIG. 14D shows the lockout indicator system immediately before thefiring system is locked from further firing. A lockout condition mayoccur after all of the surgical fasteners have been dispensed. In FIG.14D, the lockout indicator 375 has rotated so that the lockout flange394 is adjacent an edge of the lockout slot 388.

Referring to FIG. 14E, in one embodiment, as the indexer 354 movesproximally at the end of a trigger squeeze, the lockout counter 364rotates the lockout indicator 375 in a counterclockwise direction sothat the lockout flange 392 is aligned with the lockout slot 388. Oncethe lockout flange 392 is aligned with the lockout slot 388, the lockoutpin 390 drops into the lockout slot for locking the firing system. Thelockout pin 390 may be urged to drop by the lockout pin spring 394.

Referring to FIG. 15A, in one embodiment, after all of the surgicalfasteners are dispensed, the lockout indicator 375 has rotated so thatthe lockout flange 392 is aligned with the lockout slot 388. At thisstage, the lockout pin spring 394 drops the lockout pin 390 so that acatch 396 at a lower end of the lockout pin 390 is aligned with a flange345 on the yoke 342.

Referring to FIG. 15B, in one embodiment, during the next firing cyclethe yoke 342 moves distally so that the yoke flange 345 engages theproximal end of the catch 396 of the lockout pin 390. Referring to FIG.15C, in one embodiment, as the yoke moves distally, the yoke flange 345forces the catch 396 at the lower end of the lockout pin 390 to moveupwardly as the yoke 342 continues to move in a distal direction.

Referring to FIG. 15D, in one embodiment, during a later stage, the yokeflange 345 moves distal of the catch 396. In FIG. 15E, the yoke 342 isconstrained from moving in a proximal direction by the catch 396. Atthis stage, the trigger is preferably completely closed and is preventedfrom returning to the open trigger position by the engagement of thecatch 396 with the yoke flange 345.

Referring to FIG. 16A, in one embodiment, a surgical fastener 432 has adistal end 450 and a proximal end 452. The surgical fastener 432includes a first leg 454 having a first tip 456 adjacent the distal end450. The surgical fastener preferably includes a second leg 458 having asecond tip 460 adjacent the distal end 450. The proximal end 452 of thesurgical fastener 432 includes a bridge 462 connecting the first andsecond legs 454, 458. The bridge may include a concave inner surface 465and a convex outer surface 467.

Referring to FIGS. 16B and 16C, the first leg 454 desirably ends at afirst blind via 480 and the second leg 458 desirably ends at a secondblind via 482. The respective blind vias 480, 482 may be formed in thetrailing faces of the tips and are preferably located directly over thecenter of each tip 456, 460. The blind vias 480, 482 are preferablysubstantially aligned with the distal points of the tips to avoid tipbending and/or to direct forces for insertion directly behind each ofthe penetrating distal points.

Referring to FIGS. 17A-17C, in one embodiment, a surgical fastener 532includes ribs 572 provided on outer surfaces of the first and secondlegs 554, 558. The surgical fastener 532 is deployed by an insertionfork 520 having a distal end 524 with a first prong 590 and a secondprong 594. The first prong 590 includes an inner groove 592 that slidesover the first rib 572. The second prong 594 preferably includes asecond inner groove 596 adapted to slide over a second rib (not shown)on the second leg 558.

FIG. 17B shows the first and second prongs 590, 594 of the insertionfork 520 sliding over the ribs on the first and second legs of thesurgical fastener 532. FIG. 17C shows the prongs 590, 594 fully seatedover the first and second legs 554, 558 of the surgical fastener 532.The insertion fork 520 desirably provides rigidity to the surgicalfastener 532 during implantation of the surgical fastener into tissue.In one embodiment, the distal ends of the first and second prongs 590,594 are desirably axially aligned with the first and second tips 556,560 at the distal end of the surgical fastener. Insertion force ispreferably transmitted to the surgical fastener 532 by the distal endsof the tines 590, 594 and by a concave seat 525 of the insertion fork520.

Referring to FIGS. 18A and 18B, in one embodiment, a surgical fastener632 includes a first leg 654 having a first tip 656 and a second leg 658having a second tip 660. The first leg 654 includes a first groove 672that extends from a proximal end 652 toward a distal end 650 of thesurgical fastener 632. The second leg 658 has a second groove 674 thatis similarly formed as the first groove 672. As shown in FIG. 18B, thefirst pointed tip 656 is staggered from the second pointed tip 660. Thestaggered tips desirably reduce penetration force by staggering the peakforces encountered during insertion. The surgical fastener alsodesirably includes at least one barb 664 on the first leg 672 that isstaggered from the at least one barb 666 on the second leg 674.

Referring to FIGS. 19A-19C, in one embodiment, the surgical fastener 632of FIGS. 18A and 18B is implanted using an insertion tool 620 havingstaggered prongs 690A, 690B. The surgical fastener preferably includesblind vias 680, 682 that are aligned with the pointed tips 656, 660. Thestaggered prongs 690A, 690B of the insertion tool 620 are insertableinto the blind vias 680, 682 located behind the pointed tips 656,660.The prongs provide support for the surgical fastener as the fastener isimplanted, and provide an insertion force that is applied to thesurgical fastener distal to the proximal end of the surgical fastener.

FIGS. 20A-200 show the surgical fastener 632 of FIGS. 18A-18B beingimplanted using the insertion tool 620 of FIGS. 19A-19C. Referring toFIG. 20A, in one embodiment, a distal ends of an applicator instrumentis abutted against a prosthetic device 670 overlying tissue T. Theinsertion tool 620 is advanced to the distal end of the applicatorinstrument 600 so that the first and second pointed tips 656, 660 areadjacent the prosthetic device. As shown in FIG. 20A, the second pointedtip 660 engages the prosthetic device before the first pointed tip 656,thereby staggering the peak forces encountered during implantation.FIGS. 20B and 20B-1 show the pointed tips 656, 660 of the surgicalfastener 632 being pressed through the prosthetic device and into thetissue. The staggered tines 690A, 690B at the distal ends of insertiontool 620 support the pointed tips 656, 660 of the surgical fastener andpreferably extend through the prosthetic device and into the tissueduring insertion of the surgical fastener. FIG. 20C shows the surgicalfastener 632 in place for holding the prosthetic device 670 to thetissue T after the insertion tool has been retracted. The bridge 662 ofthe surgical fastener preferably overlies one of more strands of theprosthetic device for capturing the strands between the first and secondlegs 654, 658.

Referring to FIGS. 21A and 21B, in one embodiment, a surgical fastener732 includes internally facing barbs 764, 766. Referring to FIG. 21B, inone embodiment, the barbs are preferably staggered from the distal endof the surgical fastener. After implantation, the internally facingbarbs 764, 766 desirably squeeze tissue inside the legs, therebyincreasing the required pull-out force. The surgical fastener desirablyincludes a bridge 762 having a substantially flat inner surface thatallows for greater capture of the prosthetic device and further aids inalignment of the surgical fastener as it is advanced toward the distalend of an insertion tube.

Although the present invention is not limited by any particular theoryof operation, it is believed that the internally facing barbs provide agreater point to point distance for a given surgical element width,thereby reducing the chance that the surgical fastener will not capturea strand when anchoring large open-pore meshes. The internally facingbarbs enable the external surfaces of the legs 754, 758 to be straight,thereby facilitating feeding the surgical fastener inside a tube.

Referring to FIGS. 21A and 21B, in one embodiment, the legs 754, 758 ofthe surgical fastener 732 have opposing inner grooves 772, 774. Thegrooves 772, 774 are desirably accessible at the proximal end of thesurgical fastener and adjacent the bridge 762 of the surgical fastener.The inner grooves formed in the first and second legs 754, 758preferably guide tines on an insertion tool to blind vias at the distalends of the legs 754, 758. It is believed that the conical-shaped tips756, 760 increase penetration force compared to tips that are chiseled,and that the conical-shaped tips may also increase pull-out force by notcutting a path, but rather stretching the hole created by the conicaltips. FIGS. 22A-22C show an insertion tool 720 having distal tines 790A,790B that are advanceable into the inner grooves 772, 774. The distalends of the tines are preferably abutted against the blind vias 680, 682that terminate adjacent the tips 756, 760.

Referring to FIG. 23, in one embodiment, a surgical fastener 832 hasbarbs 864, 866 that are set out of plane. The out of plane barbspreferably enhance holding force after implantation in tissue. Referringto FIG. 24, in one embodiment, a surgical fastener 932 is pin-less, andis desirably pushed from a proximal end during deployment into aprosthetic device, mesh or tissue.

Referring to FIGS. 25A and 25B, in one embodiment, a surgical fastener1032 is deployed using needle-assisted insertion. The surgical fastener1032 has barbed tips 1056, 1060 having through holes. In one embodiment,the surgical fastener 1032 is made of relatively soft material, but maystill be inserted through tough prosthetic devices, meshes and tissueusing a needle-assist insertion tool 1020 having needle tips 1090A,1090B that are passable through the through holes in the tips 1056,1060.

Referring to FIG. 26, in one embodiment, a surgical fastener 1132 hasone-way barbs. Each of the barbs 1164, 1166 preferably has a notch 1165,1167 that enables the barbs to flex inwardly during insertion andoutwardly during retraction, thereby making it difficult to remove thebarbs from prosthetic devices, mesh and/or tissue during retraction ofthe surgical fastener.

Referring to FIG. 27, in one embodiment, an applicator instrument 1200has an alignment notch 1225 at a distal 1204 end therefor. As shown inFIGS. 28A and 28B, in one embodiment, the alignment notch 1225preferably facilitates aligning the instrument over a strand 1270 of aprosthetic device to insure that the strand is captured between the legs1254, 1258 of the surgical fastener 1232 when deployed from theapplicator instrument.

Referring to FIG. 29, in one embodiment, an applicator instrument 1200has an outer tube 1216 having one or more alignment markings 1290extending away from the distal end 1204 and along the outer surface ofthe outer tube 1216. The alignment marking 1290 preferably extends alongthe longitudinal axis A-A of the instrument for providing an alignmentreference marking for aligning the instrument over a strand 1270 of aprosthetic device.

The headings used herein are for organizational purposes only and arenot meant to limit the scope of the description or the claims. As usedthroughout this application, the word “may” is used in a permissivesense (i.e., meaning having the potential to), rather than the mandatorysense (i.e., meaning must). Similarly, the words “include”, “including”,and “includes” mean including but not limited to. To facilitateunderstanding, like reference numerals have been used, where possible,to designate like elements common to the figures.

While the foregoing is directed to embodiments of the present invention,other and further embodiments of the invention may be devised withoutdeparting from the basic scope thereof. As such, the scope of thepresent invention is to be limited only as set forth in the appendedclaims.

What is claimed is:
 1. A method of securing a prosthetic device totissue comprising: providing an applicator instrument including ahousing, an elongated shaft extending from the housing, a plurality ofsurgical fasteners disposed within said elongated shaft, a firing roddisposed within said elongated shaft that is moveable proximally anddistally for dispensing said surgical fasteners from the distal end ofsaid elongated shaft, a trigger for operating said applicatorinstrument, and an energy storing element disposed between said triggerand said firing rod; positioning a prosthetic device over tissue;juxtaposing a distal end of said elongated shaft with said prostheticdevice; compressing said trigger for piloting said firing rod toward thedistal end of said elongated shaft at a first rate of speed; after thepiloting step, preventing said firing rod from moving distally whilefurther compressing said trigger for building up energy in said energystoring element; after building up energy in said energy storingelement, further compressing said trigger for releasing said firing rodfor distal movement and transferring the built up energy stored in saidenergy storing element to said firing rod for moving said firing rodtoward the distal end of said elongated shaft at a second rate of speedthat is greater than the first rate of speed.
 2. The method as claimedin claim 1, wherein the built up energy transferred to said firing rodadvances the distal end of said firing rod beyond the distal end of saidelongated shaft for driving a leading one of said surgical fastenersthrough said prosthetic device and into the tissue for securing saidprosthetic device to the tissue.
 3. The method as claimed in claim 2,further comprising repeatedly pulling said trigger for dispensing one ofsaid surgical fasteners from the distal end of said elongated shaft eachtime said trigger is pulled.
 4. The method as claimed in claim 1,further comprising during the piloting step moving said firing roddistally at the first rate of speed that is proportional to the movementof said trigger.
 5. The method as claimed in claim 4, further comprisingduring the piloting step engaging a distal end of said firing rod with aleading one of said surgical fasteners.
 6. The method as claimed inclaim 1, wherein said energy storing element comprises a firing springdisposed between said trigger and said firing rod.
 7. The method asclaimed in claim 6, further comprising before the piloting step at leastpartially compressing said firing spring, and during the piloting stepmaintaining the compression level of said firing spring so that thecompression level does not change.
 8. The method as claimed in claim 7,further comprising during the building up energy step increasing thecompression level of said firing spring.
 9. The method as claimed inclaim 1, wherein said energy storing element is selected from the groupconsisting of a firing spring, a pneumatic device, a hydraulic device, acompressed gas device, and combinations thereof.
 10. The method asclaimed in claim 1, further comprising: providing an advancer disposedwithin said elongated shaft, wherein said advancer is coupled with saidtrigger and is adapted to move toward the distal end of said elongatedshaft when said trigger is compressed and to move toward the proximalend of said elongated shaft when said trigger is opened; after thetransferring the built up energy step, compressing said trigger formoving said advancer toward the distal end of said elongated shaft,whereby the distally moving advancer shifts each of said surgicalfasteners disposed within said elongated shaft one position closer tothe distal end of said elongated shaft.
 11. A method of securing aprosthetic device to tissue comprising: providing an applicatorinstrument including a housing, a shaft extending from said housing,surgical fasteners disposed within said shaft, a firing system fordispensing said surgical fasteners from a distal end of said shaft, anda trigger for activating said firing system, said firing systemincluding a firing rod disposed in said shaft, an energy storing elementcoupled with said firing rod, and a firing rod release engageable withsaid firing rod for preventing distal movement of said firing rod duringat least one stage of a firing cycle; placing a prosthetic device overtissue; during an initial stage of a firing cycle, with said trigger inan open position, juxtaposing a distal end of said shaft with saidprosthetic device; during a piloting stage of a firing cycle,compressing said trigger for advancing said firing rod toward the distalend of said shaft at a first rate of speed that is proportional to themovement of said trigger; during an energy storing stage of said firingcycle, further compressing said trigger for building up energy in saidenergy storing element as said firing rod release holds said firing rodstationary so that said firing rod cannot move toward the distal end ofsaid shaft; during a firing stage of said firing cycle, furthercompressing said trigger so that said firing rod release automaticallydisengages from said firing rod whereupon the built up energy in saidenergy storing element is transferred to said firing rod for advancingsaid firing rod toward the distal end of said shaft at a second rate ofspeed that is greater than the first rate of speed.
 12. The method asclaimed in claim 11, wherein the piloting stage of said firing cyclefurther comprises coupling a distal end of said firing rod with aleading one of said surgical fasteners.
 13. The method as claimed inclaim 12, wherein the firing stage further comprises dispensing saidleading one of said surgical fasteners from the distal end of said shaftand through said prosthetic device for securing said prosthetic deviceto the tissue.
 14. The method as claimed in claim 13, wherein the firingstage further comprises advancing the distal end of said firing roddistally beyond the distal end of said shaft for driving said leadingone of said surgical fasteners through said prosthetic device and intothe tissue.
 15. The method as claimed in claim 11, wherein said energystoring element comprises a firing spring, and the firing stage furthercomprises transferring the built up energy in said firing spring to saidfiring rod for advancing said firing rod distally toward the distal endof said shaft.
 16. The method as claimed in claim 15, wherein saidfiring spring has a first end connected with said firing rod and asecond end that is sequentially coupled and decoupled from said triggerduring said firing cycle.
 17. The method as claimed in claim 11, whereinduring the firing stage the second rate of speed is greater than boththe first rate of speed and the movement of said trigger.
 18. A methodof securing a prosthetic device to tissue comprising: providing anapplicator instrument including a housing, a shaft extending from saidhousing, a firing system, and a trigger for activating said firingsystem; positioning a prosthetic device over tissue; juxtaposing adistal end of said shaft with said prosthetic device positioned over thetissue; compressing said trigger whereupon said firing system advancessaid firing rod toward the distal end of said shaft at a first rate ofspeed that is proportional to the movement of said trigger; furthercompressing said trigger whereupon said firing system holds said firingrod stationary so that said firing rod cannot move toward the distal endof said shaft as energy is built up in said firing system; still furthercompressing said trigger whereupon said firing system automaticallyreleases said firing rod and the built up energy in said firing systemis transferred to said firing rod for advancing said firing rod towardthe distal end of said shaft at a second rate of speed that is greaterthan both the first rate of speed and the movement of said trigger. 19.The method as claimed in claim 18, wherein after said firing systemreleases said firing rod, the built up energy in said firing systemdrives the distal end of said firing rod distally beyond the distal endof said shaft for dispensing a leading one of said surgical fastenersfrom the distal end of said shaft.
 20. The method as claimed in claim19, further comprising, after dispensing the leading one of saidsurgical fasteners, further compressing said trigger for decoupling saidtrigger from said firing system whereupon said firing rod is free tomove toward the proximal end of said shaft.
 21. A method of securing aprosthetic device to tissue comprising: providing an applicatorinstrument having a housing, an elongated shaft projecting from saidhousing, and a firing system including a firing rod for dispensingsurgical fasteners from a distal end of said elongated shaft; placing aprosthetic device over tissue and juxtaposing the distal end of saidelongated shaft over said prosthetic device; aligning a surgicalfastener with a distal end of said firing rod; advancing the distal endof said firing rod toward said surgical fastener at a first speed forengaging said surgical fastener; after the firing rod advancing step andwhile said firing system constrains said firing rod from moving towardthe distal end of said elongated shaft, building up energy in saidfiring system; after the building up energy step, said firing systemautomatically releasing said firing rod and transferring the built upenergy to said firing rod for driving said firing rod distally at asecond speed that is greater than the first speed so as to dispense saidsurgical fastener from the distal end of said elongated shaft.
 22. Themethod as claimed in claim 21, wherein said firing system desirablyincludes a compressible firing spring coupled with said firing rod, andan actuator coupled with said firing spring for selectively compressingsaid firing spring for building up energy in said firing system.
 23. Themethod as claimed in claim 22, pre-compressing said firing spring priorto actuation of said applicator instrument, and increasing thecompression level of said firing spring during the building up energystep.